FDA Adverse Event Injury Summary report: N

FREESTYLE LIBRE 3 SENSORS

MDR report key: 20111534 · Received August 29, 2024

Report

Report Number
MW5159121
Event Type
Injury
Date Received
August 29, 2024
Date of Event
August 1, 2024
Report Date
August 26, 2024
Manufacturer
ABBOTT DIABETES CARE INC.
Product Code
QBJ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

MADE UNSAFE MEDICAL DECISIONS BASED ON INCORRECT SENSOR READINGS. SEE ADDITIONAL COMMENTS BELOW FOR THE MAJORITY OF MY COMMENTS. FOR SEVERAL MONTHS. WHEN USING FREESTYLE LIBRE 3 SENSORS, I HAVE HAD READINGS THAT ARE 80-120 POINTS DIFFERENT FROM FINGER STICK-READINGS. I HAVE REPORTED THESE READINGS TO MY DOCTORS AND BASED ON HIGH READINGS, HAVE TAKEN EXTRA FAST ACTING INSULIN TO TRY TO LOWER READING WHICH HAVE CAUSED EXTREME DROWSINESS. WHEN LOW READINGS, I HAVE TAKEN RESCUE FOODS LIKE HONEY OR SUGAR TO TRY TO RAISE READING WHICH HAVE MADE MY HEART RACE, CAUSED SHAKING, SWEATING AND NON-FUNCTIONING WEAKNESS. I HAVE ALMOST CALLED 911 FOR HELP BUT TOO WEAK TO THINK CLEARLY. I OFTEN WONDERED WHY THE READINGS HAVE BEEN SO EXTREME AND WONDERED ABOUT THE QUALITY OF THE PRODUCT I WAS TRUSTING. IT HAS BEEN A ROLLER COASTER EFFECT WITH THE EXTREME HIGHS AND LOWS READINGS. IT HAS BEEN FRUSTRATING WHEN THE SENSORS QUIT WORKING AFTER A FEW DAYS, NOT THE FILL 14 DAYS, ALSO THE ALARMS RINGING DANGER WHEN IN FACT THE SENSOR READINGS WERE INCORRECT. MY DOCTORS AND I COUNT ON MAKING MEDICAL DECISIONS BASED ON THE READINGS. ON AUGUST 26, 2024 @ AROUND 5:15 PM I CALLED THE ABBOTT CUSTOMER SERVICE @ 833-815-4273. SPOKE WITH (B)(4) OR A NAME THAT WAS NOT CLEAR AND SHE SAID THAT EVEN THOUGH THE LOT IS RECALLED, TO CONTINUE USING THE BOXES BECAUSE SHE SAID THE SERIAL NUMBERS ARE OK UNDER THE RECALLED LOT NUMBER: T60001969. SHE WAS VERY RUDE AND ASKED IF I COULD GIVE ALL THE SENSOR READINGS. I TOLD HER THE DOCTOR HAS TRACKED THESE READINGS SO SHE DISMISSED ME AND SAID SHE COULD NOT HELP AND TO USE THE RECALLED SENSOR NUMBERS. SHE OFFERED POOR CUSTOMER SERVICE AND DID NOT CARE THAT I WAS GOING TO CONTACT THE FDA. SHE CONTINUED TO IGNORE AND TALK OVER ME. I WAS SHOCKED AT HER RUDENESS EVEN THOUGH I TOLD HER I DIDN'T FEEL SAFE USING THE UNOPENED BOXES WITH THE RECALLED URGENT MEDICAL DEVICE CORRECTION NOTICE THAT I RECEIVED. NOW I SEE WHY MY DOCTOR HAS MENTIONED CHANGING TO DEXCOM. THIS EMPLOYEE DOESN'T SEEM TO SUPPORT ABBOTT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1833936 FREESTYLE LIBRE 3 SENSORS INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC. T60001969

Patients

Seq Age Sex Outcome Treatment
1 Female Other| R