MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE 2; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

I am lodging a complaint regarding the fda's requirement that continuous glucose monitors, such as the abbott laboratories freestyle libre 2 and 3 and dexcom g6, include mandatory critical alerts (also known as "urgent low" glucose alarms).These alarms have an extremely loud and painfully high-pitched volume, which cannot be silenced by the patient.As a type 1 diabetic who uses continuous glucose monitors to help manage my condition, it is my experience that these mandatory alerts are extremely disruptive and render these life-changing devices virtually unusable.Those of us who work in a corporate office setting and/or wish to keep our health condition discreet, simply cannot have these screeching alarms going off in the workplace.The notion that an adult human being would not be allowed to silence these critical alerts when desired (e.G., while at work, church, class, meetings, during an interview, etc.) is completely unacceptable.By not allowing patients the option of silencing these alarms, the fda is effectively taking away our basic dignity and right to privacy.It is my observation that these types of mandatory alerts promote alarm fatigue and could ultimately result in a significant number of patients doing away with continuous glucose monitors altogether (which would be at travesty and highly detrimental to their blood glucose management).In closing, i would like to mention that most patients who use these continuous glucose monitors are probably not aware that the fda has required these mandatory critical alerts.As a result, the majority of patients have lodged their complaints directly with the manufacturers rather than the fda.I would encourage the fda to engage with the manufacturers on patient feedback and investigate product reviews (apple app store, google play store, etc.) to see how other patients have been negatively affected by this requirement.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 16226219
• MDR Text Key: 308042660
• Report Number: MW5114435
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: NOVOLOG; TRESIBA
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White