Libre App 78746-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00357599841003), received between Oct 15, 2025 and Mar 26, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K233537); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026

  EXPERIENCING LOW GLUCOSE READINGS - 10-20 POINT BELOW WHAT I FIND WITH A MANUAL FINGER-STICK CHECK. THIS HAS BEEN HAPPENING SINCE I STARTED THE MONITOR 9 DAYS AGO. SINCE THE GAP WAS DECREASING AND I THOUGHT IT WAS GETTING BETTER, SO CONTINUED TO USE, BUT GAP HAS WIDENED AGAIN. READINGS ARE CONSISTENTLY INACCURATE. NEED REPLACEMENT AND TO GET BACK ON TRACK WITH MORE RELIABLE RECORDING/REPORTING.

  Patient problems: Hypoglycemia

  MAUDE report 24701665 ↗
• InjuryOct 15, 2025Application Program Problem; Audible Prompt/Feedback Problem; Application Program Problem; Audible Prompt/Feedback Problem

  A COMPLAINT WAS RECEIVED VIA SOCIAL MEDIA IN WHICH A SOUND ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH UNKNOWN IPHONE WITH UNKNOWN IOS OPERATING SYSTEM. CUSTOMER REPORTED ¿I HAVE A PROBLEM WITH ALARMS NOT BEING HEARD. I REQUIRE A WATCH TO MONITOR SLEEP AND HEART FUNCTIONS. LIBRE ALARMS ON WATCH ARE MUTED. I MUST SET LOUD INSISTENT ALARMS ON MY PHONE TO WAKE ME EVERY TWO HOURS AND CHECK LIBRE VALUES. EARLIER THIS YEAR A FAILURE TO WAKE ME LEFT ME IN A DIABETIC COMA AND ALMOST DYING.¿ NO FURTHER DETAILS WERE PROVIDED AND ATTEMPTS TO GATHER ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23304453 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K233537. One submission often covers many models, so check the product and lot details in each record.

• Z-1021-2026 · Nov 24, 2025 · Open, Classified
  FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring Syst
• Z-1022-2026 · Nov 24, 2025 · Open, Classified
  FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring Syst