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

Device Problems Device Alarm System (1012); Patient Device Interaction Problem (4001)

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

Event Date 04/27/2023

Event Type  Injury  

Event Description

My father is using a diabetic monitor.Abbott's libre2.The device settings do not allow a person with hearing loss to hear the warning alarm for high blood sugar because of the high frequency of the sound.It's in a pitch range that he cannot hear.It is not a problem with the volume.The alarm was screaming and he couldn't hear it at all.Device manufacturers need to create an app alarm that can be heard by those with hearing loss.The device only allows the alarm they created or one other sound native to the iphone operating system.That sound, albeit lower in pitch, is unfortunately a common one that sounds more like an incoming email and not an alarm.Please review apps by all brands for medical devices and make sure they come with alarms that can be heard by people who can't hear high frequencies (a regular occurrence of aging and/or a common disability).Thank you.

• Brand Name: LIBRE 2 APP
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 16876882
• MDR Text Key: 314733260
• Report Number: MW5117255
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BLOOD PRESSURE MED; BLOOD THINNERS; INSULIN ; PROSTATE CANCER DRUGS; STATINS
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White