FreeStyle Libre 3 78754 (UDI 00357599842000)Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Libre 3 Continuous Glucose Monitoring System Reader · Class 2
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00357599842000), received between Nov 27, 2024 and Sep 17, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (9 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Alarm System9
- Incorrect, Inadequate or Imprecise Result or Readings1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804346 ↗MalfunctionAug 30, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50510483 ↗MalfunctionAug 28, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50499172 ↗MalfunctionAug 28, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50494914 ↗MalfunctionAug 28, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50494744 ↗MalfunctionAug 27, 2026Device Alarm System
A customer reported a missing high/low glucose alarm with the ADC device. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50467967 ↗MalfunctionAug 26, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50448774 ↗MalfunctionAug 26, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50448753 ↗MalfunctionAug 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50434940 ↗MalfunctionAug 17, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50277041 ↗MalfunctionNov 27, 2024Product Quality Problem; Product Quality Problem
CUSTOMER REPORTS WHILE CHARGING THEIR ABBOTT DIABETES CARE DEVICE, VISIBLE SMOKE WAS OBSERVED FROM THE CHARGING PORT. THERE WAS NO REPORT OF FIRE, EXPLOSION, OR SHOCK. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20797715 ↗
Other System, test, blood glucose, over the counter devices
- OneTouch Verio Flex 023-271LifeScan Europe GmbH · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER3,703 reports
- FreeStyle Libre 2 71953Abbott Diabetes Care Inc · System, test, blood glucose, over the counter2 recalls1 death3,286 reports
- OneTouch Ultra2 021-105LifeScan U.S. LLC · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER1,731 reports
- Omnipod DASH PDM PDM-USA1-D001-MG-USA1Insulet Corporation · System, Test, Blood Glucose, Over The Counter1 recall10 deaths1,129 reports
- Omnipod UST400Insulet Corporation · System, Test, Blood Glucose, Over The Counter12 deaths816 reports
- TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALETrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter418 reports
- FreeStyle Freedom Lite 70923-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
- FreeStyle Lite 70829-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.