FREESTYLE LIBRE THREE PLUS
Received Jun 22, 2026 · Event occurred Jun 17, 2026
Report MW5189691 · MDR key 25578719
Device
Generic name
Integrated Continuous Glucose Monitoring System, Factory Calibrated
Manufacturer
Abbott Diabetes Care LimitedProduct problems
- False Alarm
- Failure to Power Up
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
50 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ABBOTT FREESTYLE LIBRE THREE PLUS. THE MOST RECENT SENSOR OR CONTINUOUS GLUCOSE MONITOR OR "CGM" HAD A 50-90 POINT DISCREPANCY. THAT WOULD MEAN THAT I WOULD DO A BLOOD TEST ON A DIFFERENT GLUCOSE METER THAT WOULD READ 120 (80-130 IS CONSIDERED "NORMAL RANGE" BY THE AMERICAN DIABETES ASSOCIATION. WHEN A DIABETIC ON INSULIN, THAT IS USUALLY WHO ARE TYPICALLY PRESCRIBED A "CGM" TAKES MEDICATION OR MAKES MEDICATION DECISIONS ON THESE SENIORS, USUALLY WHEN THE GLUCOSE IS HIGH. IT IS TYPICAL PROTOCOL TO DOUBLE CHECK LOW GLUCOSE (BELOW 70ML) BUT HIGH GLUCOSE ISN'T ALWAYS CONFIRMED. I TOOK QUICK ACTING INSULIN AND HAD A LOW BECAUSE OF THIS INCIDENT. I WOULD LOVE TO SAY THAT THIS WAS THE ONLY ISSUE I HAVE HAD WITH ABBOTT. I HAD 11 BAD SENSORS IN A ROW A FEW MONTHS AGO. MEANING, DEAD OUT OF THE BOX, OR READINGS AS DESCRIBED ABOVE, EITHER VERY HIGH OR VERY LOW WITH ALARMS THAT WERE FALSE WAKING ME UP ALL NIGHT TO INDICATE LOW SUGAR. I CALLED EVERY TIME, BECAUSE I WANTED TO ANSWER QUESTIONS AND POSSIBLY HELP THEIR QUALITY CONTROL ISSUES. AFTER ABOUT 10 BAD SENIORS, THEY SENT ME TO SPEAK WITH A MANAGER, BECAUSE THEY DIDN'T WANT TO REPLACE MORE SENSORS. I EXPLAINED THAT I COULD SEND ANY DATA TO BACK UP MY CLAIMS, BUT THEY HAD THE QUALITY ISSUE, NOT PAYING CUSTOMER ISSUE. THAT IN ITSELF WAS OUTRAGEOUS TOO, BECAUSE WE ARE PAYING AROUND $40 A MONTH FOR BAD QUALITY PRODUCTS. WHY IS THIS ALLOWED? PLEASE HELP ME UNDERSTAND WHY CORPORATIONS ARE ALLOWED TO WALK OVER CONSUMERS? I AM NOT THE ONLY PERSON WITH THESE ISSUES. PLEASE GO ON ANY DIABETES FORUM OR GROUP ON REDDIT OR FACEBOOK AND YOU WILL SEE THIS IS A KNOWN ISSUE. I UNDERSTAND THERE IS ROOM FOR ERROR, BUT THIS IS A CORPORATION THAT IS ALLOWED TO GET AWAY WITH HARMFUL PRACTICES AND HORRIBLE QUALITY CONTROL. THEY ALLOW FOR A MARGIN OF 20% ERROR; I WOULD BE FIRED FROM WORK WITH THAT TYPE OF LEEWAY. THIS IS HARMFUL AND MUST BE INVESTIGATED. PLEASE MAKE THESE CORPORATIONS SELL PRODUCTS THAT DO NOT HARM PEOPLE THAT ALREADY LIVE WITH A VERY DIFFICULT ILLNESS, DIABETES. THIS SHOULD NOT BE ACCEPTABLE IN AMERICA. PT: 4582. DEVICE: 1535, 1476, 1013. THIS REPORT CAPTURES FREESTYLE LIBRE THREE PLUS #7. REF: MW5189685, MW5189686, MW5189687, MW5189688, MW5189689, MW5189690, MW5189692, MW5189693, MW5189694, MW5189695.