FreeStyle Libre 2 App 71857-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00357599809003), received between Aug 10, 2023 and Sep 9, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Application Program Problem” (3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2024Device Alarm System; Application Program Problem; Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH GOOGLE PIXEL 6 WITH ANDROID OPERATING SYSTEM VERSION 14. THE CUSTOMER RECEIVED A SIGNAL LOSS AND WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS SEIZURE, "FELT SORE AND TIRED", BUT WAS ABLE TO SELF-TREAT BY DRINKING JUICE. THERE WAS NO THIRD-PARTY TREATMENT/MEDICATION PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Convulsion/Seizure; Hypoglycemia

  MAUDE report 20169926 ↗
• InjuryJun 18, 2024Device Alarm System; Application Program Problem; Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE MOTO G STYLUS 5G ANDROID OPERATING SYSTEM VERSION 13. CUSTOMER EXPERIENCED A SIGNAL LOSS AND WAS UNABLE RECEIVE GLUCOSE ALARMS. AS A RESULT, CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL AND EXPERIENCED SYMPTOMS REPORTED AS LOSS OF CONSCIOUSNESS, ¿MOANING AND MOVING IN BED AND CRYING, THEY STAYED LOW¿ AND WAS UNABLE TO SELF-TREAT, REQUIRING THIRD-PARTY TREATMENT OF HONEY BY A NON-HEALTHCARE PROFESSIONAL BEFORE CONTACT WAS MADE WITH EMERGENCY SERVICES (ES). UPON ARRIVAL, THE HEALTHCARE PROFESSIONAL (HCP) PERFORMED HEART MONITORING MEASURES AND SUGGESTED TOAST WITH BUTTER AND PEANUT BUTTER FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Fatigue; Loss of consciousness

  MAUDE report 19558499 ↗
• InjuryAug 10, 2023Application Program Problem; Application Program Problem

  ABBOTT DIABETES CARE RECEIVED A MEDWATCH REPORT WHICH REPORTED THE FOLLOWING INFORMATION: A COMPATIBILITY ISSUE WAS REPORTED WITH AN ABBOTT DIABETES CARE (ADC) APPLICATION IN USE WITH A MOTOROLA MOTO G PURE (WITH STYLUS) PHONE WITH ANDROID VERSION UNSPECIFIED OPERATING SYSTEM. CUSTOMER WAS UNABLE TO USE THE APPLICATION TO MONITOR GLUCOSE LEVELS. ADC CUSTOMER SERVICE ATTEMPTED TO CONTACT THE REPORTER THREE TIMES TO GAIN ADDITIONAL DETAILS REGARDING THIS EVENT, HOWEVER ALL FOLLOW UP ATTEMPTS WERE UNSUCCESSFUL. BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT OF SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17499956 ↗