A review of the 2024 MedTech device-related adverse events and product issues for 2024 as revealed by FDA’s MAUDE (Manufacturer and User Facility Device Experience) database and analyzed using Redica Systems reports shows events and trends worth highlighting, in particular for integrated continuous glucose monitoring (iCGM) systems and CPAP machines.
First a few caveats. Reports in MAUDE are not verified by FDA, may contain inaccurate or incomplete information, and do not contain information regarding the frequency of device use. In addition, although reports should be filed within specified timelines (5, 10, or 30 days in accordance with § 803.53(b)), delays are common and unavoidable when initial data is incomplete or not properly reported to the manufacturer. Keeping this in mind, MAUDE data remains an important primary data source for quality monitoring, postmarket surveillance, risk management, and management review. (see Keys to Accurately Analyzing FDA’s MAUDE Database¹ for a more in-depth discussion of the MAUDE database and best practices on understanding and using the data).
Integrated Continuous Glucose Monitors
Integrated continuous glucose monitoring (iCGM) systems (FDA Product Code QBJ) are important tools in patient monitoring of blood glucose levels and the management of diabetes for children and adults.
An iCGM is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices.
iCGMs are used at home by patients in conjunction with the associated transmitter and receiver to monitor glucose levels for the management of diabetes.
In March 2018 FDA cleared the first fully interoperable continuous glucose monitoring system, the Dexcom G6, for determining blood glucose (sugar) levels in children aged two and older and adults with diabetes.² This was the first type of continuous glucose monitoring system permitted by the agency to be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management.
In December 2022, Dexcom received clearance l for its G7 device, an upgrade from the G6 with improved accuracy. Abbott, Dexcom, and Medtronic are the leading manufacturers in the US $11B iCGM market.
In a survey of MAUDE events over the past two years, iCGM systems have drawn attention based on a 10% increase in reported events and a 275% increase in events that may have caused or contributed to patient death.
Figure 1 | MAUDE Event Trends
Regarding these events, the data show a steady increase in injuries in 2024. Most injuries were associated with incorrect, inadequate, or imprecise readings. Wireless communication problems (87,770 events) and incorrect, inadequate readings (28,567 events) top the list of malfunctions (data from January 1, 2024 through August 31, 2024).
Figure 2 | MAUDE Events Over Time by Event Type
Figure 3 | MAUDE Events by Trade Name
Examining recalls for iCGM products, there have been no reported recalls for product code QBJ since 2021. However, a similar product with product code QLG – Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not for Use With Automated Insulin Delivery Systems – has experienced product recalls.
The products coded QLG also automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. The systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The difference with product code QBJ is the system is not intended to be used with automated insulin dosing (AID) systems.
Abbott’s FreeStyle Libre 3 iCGM is classified as QLG. The company received FDA clearance for its associated reader for the FreeStyle Libre 3 in April 2023 and describes the product as “the most prescribed and affordable integrated continuous glucose monitoring (iCGM) system in the United States.”² The product has experienced Class I recalls for process and device design and Class II recalls for software design and design changes:
Figure 4 | Recall Trends Data
Continuous Positive Airway Pressure (CPAP) Machines
CPAP (Continuous Positive Airway Pressure) designates a specific type of positive airway pressure (PAP) therapy used to treat Obstructive Sleep Apnea (OSA), a sleep-related breathing disorder caused by blocked or collapsed airways.
Respironics is an American medical supply company owned by Philips that specializes in products that improve respiratory functions such as CPAP machines. It had a significant number of MAUDE-reportable events in 2024.
There are several product codes that map to various types of CPAP and related ventilator products. The one with the largest number of events in 2024 is a CPAP machine, product code BZD (ventilator, non-continuous (respirator):
Figure 5 | MAUDE Events by Product Code
Looking at MAUDE events over time by event type in 2024, total events are up 94% to 50,758 compared with 26,214 in the previous year:
Figure 6 | MAUDE Event Trends
In addition, the data show a 535% increase in MAUDE events with Death to 1,942 compared to 306 for the previous period. Even without the unexplained spike in May 2024, a steady increase is noted:
Figure 7 | MAUDE Events Over Time by Event Type
More than 80% of reported events classified as Death are associated to “degraded,” with 12 % “adverse event without identified device or use problem” and 2% “insufficient information.”
Other Recent Philips Respironics Issues with CPAP Products
In June 2021, Philips issued a Class I recall for its CPAP, BiPAP (Bilevel Positive Airway Pressure) and ventilator devices after lab tests revealed the polyester-based polyurethane (PE-PUR) foam used for sound abatement could break down and particles and gasses from degraded foam could be inhaled or ingested and cause serious toxic and carcinogenic health problems. Philips credited high humidity and the use of ozone cleaners as possible contributors to the foam degradation. These recalls impacted 15 million devices worldwide and the defect could be classified as “degraded.”
On April 9, 2024, a U.S. federal court issued a consent decree4 that bans the company from distributing sleep apnea machines in the U.S. and halts production until several requirements have been met. Philips must also hire independent safety experts to oversee the process and submit to facility inspections for five years. The company’s efforts to remediate the PE-PUR foam in those recalled devices are ongoing, and some of the remediated devices have themselves been the subject of additional recalls.
In May 2024 it was announced that Philips had reached $1.1 Billion settlement with regard to the defective CPAP machines.
On October 31, 2024, a Pennsylvania federal judge granted final approval for Philips Respironics’ proposed $25 million settlement of medical monitoring claims in which plaintiffs alleged that its recalled sleep apnea machines exposed them to cancerous particles and fumes.
Conclusion
MAUDE data is a valuable resource for medical device professionals seeking to enhance product safety, quality, and compliance. However, it is crucial to approach MAUDE data with a critical eye and a deep understanding of its regulatory framework.
Analysis of 2024 data on iCGM systems showed a marked increase in reported events shows a steady increase in injuries in 2024, mostly associated with incorrect, inadequate, or imprecise readings. Wireless communication problems and incorrect, inadequate readings top the list of malfunctions.
The causes of injuries and malfunctions can be used by manufacturers of similar devices as target areas to evaluate, allowing the company to mitigate risks, improve device design, and enhance patient outcomes. Class I and II recalls due primarily to software and device design issues can also be examined in a similar way.
2024 data on CPAP machines showed events for Philips Respironics up 94% in 2024 and events associated with death up 535%. Ongoing problems with its CPAP machines continue issues that began with Class I recalls in 2021 and resulted in a consent decree earlier this year. Other companies manufacturing similar equipment would do well to review any sound abatement measures put in place. No other event reasons reported are particularly actionable.
¹ https://redica.com/keys-to-accurately-analyzing-fdas-maude-database/
³ https://abbott.mediaroom.com/2023-04-14-FDA-Clears-Reader-for-Abbotts-FreeStyle-Libre-R-3-System
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