MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE; SENSOR, GLUCOSE, INVASIVE

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hypoglycemia (1912); Syncope/Fainting (4411)

Event Date 05/18/2022

Event Type  Injury  

Event Description

I use the abbott freestyle libre to monitor my blood glucose.On the 18th, i received a error message that my sensor ended and i needed to reapply a sensor, however i had applied and activated a new sensor before going to bed.I contacted abbott about my problem and they sent me a new sensor.I reapplied the new sensor and received another error message on may 24th.I contacted abbott again and they sent me another sensor.I also contacted my endocrinologist to let her know about my problem with my freestyle libre and to request testing strips for my onetouch verio flex strips.This time, i used my old freestyle libre to see if maybe my meter was the problem.1 week after activating my new sensor with my old meter, i received the message that my sensor had ended.I'm hesitant to refill my freestyle libre sensor prescription due to all of the recent sensor malfunctions.I have had multiple episodes of hypoglycemia, one of which occurred at work and led to a syncopal episode.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE, INC.
• MDR Report Key: 14695702
• MDR Text Key: 294245499
• Report Number: MW5110326
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/10/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: FREESTYLE LIBRE METER (OLD); ONETOUCH VERIO FLEX STRIPS
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White