MAUDE Adverse Event Report: ABBOT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY CONTINUOUS GLUCOSE MONITOR; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Device Problems Unable to Obtain Readings (1516); Defective Device (2588); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 11/13/2021

Event Type  malfunction  

Event Description

Freestyle libre failed to operate.I have been using these for over 3 years.I know how to use and apply them to my arm properly.I have had 2 complete failures in the last 2 months, plus one failure after 1 and a half days in the last 2 months.I apply to my arm.I activate it.Per the manufacturers instruction, readings are not available for the 1st hour.On 2 applications, the device started up properly.After 1 hour, i try to take a reading and the error message comes back that the device is not working.Apply another device.1 time the device worked for a day and a half and then quit abruptly.It is supposed to work for 14 days.Abbott has a helpline, but it is little help.They have people form foreign countries answering the phone who keep asking for information that is not available.(they want to know about error messages and their devices don't retain any messages) they keep you on the line for 20 to 30 minute.Every time that you give them an answer, they put you on hold for 5 to 10 minutes.They are reading from a script and if you are not following the script, you will suffer by longer and longer times on hold.Abbott's devices should not be failing this often.There is some kind of lack in oversight of production.Too many device failures of this cgm that the fda has approved.Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAY CONTINUOUS GLUCOSE MONITOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOT DIABETES CARE INC.
• MDR Report Key: 12835308
• MDR Text Key: 281110750
• Report Number: MW5105412
• Device Sequence Number: 1
• Product Code: PZE
• 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
• Report Date: 11/15/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• 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: SUPPLEMENTS; VITAMINS
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White