FreeStyle Libre 2 App 71926-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00357599810009), received between Oct 12, 2023 and Jun 19, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Application Program Problem” (13 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2025Application Program Problem; Application Program Problem

  ABBOTT DIABETES CARE RECEIVED A MEDWATCH REPORT WHICH REPORTED THE FOLLOWING INFORMATION PERTAINING TO AN ABBOTT DIABETES CARE (ADC) APPLICATION: THE CUSTOMER REPORTED THAT THEIR IPHONE HAD UPGRADED TO IOS OPERATING SYSTEM VERSION 18.4, AND SINCE THEN THE GLUCOSE MONITORING ON THE FREESTYLE LIBRE 2 APPLICATION WOULD "STALL" OR "NOT WORK" DUE TO INCOMPATIBILITY ISSUES WITH THE APPLICATION VERSION. THERE WAS NO REPORT OF ADVERSE EVENT OR THIRD-PARTY MEDICAL TREATMENT PROVIDED FOR THE REPORTED ISSUE. ADC CUSTOMER SERVICE ATTEMPTED TO CONTACT THE CUSTOMER 3 (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 22290128 ↗
• InjuryJan 6, 2025Device 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 IPHONE 11 WITH IOS OPERATING SYSTEM VERSION 18.2. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS AND UNABLE TO SELF-TREAT, REQUIRING ORANGE JUICE PROVIDED BY NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 21085161 ↗
• InjuryDec 30, 2024Unable to Obtain Readings; Device Displays Incorrect Message; Application Program Problem; Unable to Obtain Readings; Device Displays Incorrect Message; Application Program Problem

  AN ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH AN UNKNOWN PHONE WITH UNKNOWN OPERATING SYSTEM AND WITH UNKNOWN APP VERSION. THE CUSTOMER RECEIVED A "REPLACE SENSOR" MESSAGE AND WAS UNABLE TO OBTAIN GLUCOSE READINGS. THE CUSTOMER EXPERIENCED LOSS OF REFERENCE POINTS, IMBALANCE, ¿LESS REFLECTION¿ AND WAS UNABLE TO SELF-TREAT, REQUIRING THIRD-PARTY ADMINISTRATION OF YOGURT AND COMPOTE FROM A NON-HEALTHCARE PROFESSIONAL FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Cognitive Changes; Hypoglycemia

  MAUDE report 21036410 ↗
• 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 IPHONE PHONE WITH IOS OPERATING SYSTEM VERSION _17.6.1. THE CUSTOMER EXPERIENCED A SIGNAL LOSS AND WAS UNABLE TO RECEIVE GLUCOSE ALARMS. AS A RESULT, THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL AND EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING AN INTRAVENOUS INJECTION BY HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 20169374 ↗
• InjuryAug 13, 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 IPHONE PHONE WITH IOS OPERATING SYSTEM VERSION 17.5.1. THE CUSTOMER EXPERIENCED A SIGNAL LOSS AND WAS UNABLE RECEIVE GLUCOSE ALARMS. AS A RESULT, THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL AND EXPERIENCED SYMPTOMS DESCRIBED AS "HOT, SHAKING, WEAK AND ALMOST A LOSS OF CONSCIOUSNESS" AND WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT OF GLUCAGON BY NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Fatigue; Hypoglycemia; Shaking/Tremors

  MAUDE report 19970875 ↗
• InjuryJul 16, 2024Unable to Obtain Readings; Device Displays Incorrect Message; Unable to Obtain Readings; Device Displays Incorrect Message

  AN ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) APPLICATION IN USE WITH IPHONE (UNSPECIFIED MODEL), WITH IOS 17.5.1, AND WITH A SOFTWARE VERSION 2.7.5.4061. THE CUSTOMER RECEIVED A "REPLACE SENSOR" ERROR MESSAGE AND WAS UNABLE TO OBTAIN READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS "DIFFICULTY EATING AND SEEING", AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS UNABLE TO SELF-TREAT, REQUIRING NON-HEALTHCARE PROFESSIONAL (NON-HCP) ADMINISTRATION OF "7-UP AND BANANA" FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 19752468 ↗
• InjuryJul 10, 2024Unable to Obtain Readings; Device Displays Incorrect Message; Unable to Obtain Readings; Device Displays Incorrect Message

  A "SENSOR ENDED" ERROR MESSAGE WAS REPORTED WITH THE USE OF THE ABBOTT DIABETES CARE (ADC) DEVICE AND CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. AS A RESULT, CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING HEALTHCARE PROFESSIONAL ADMINISTRATION OF GLUCOSE INJECTION FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 19709032 ↗
• InjuryJul 2, 2024Application Program Problem; Application Program Problem

  AN AUTHENTICATION ERROR WAS REPORTED WITH THE FREESTYLE LIBRE APP. THE CUSTOMER REPORTED ENCOUNTERING ¿FEATURE NOT AVAILABLE¿ ERROR MESSAGE. THE CUSTOMER EXPERIENCE LOSS OF CONSCIOUSNESS. THERE WAS NO REPORT OF THIRD-PARTY INTERVENTION, AND NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 19658699 ↗
• InjuryMay 23, 2024Device Alarm System; Device Alarm System

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH THE IPHONE 13 WITH IOS OPERATING SYSTEM VERSION 17.1.1. THE CUSTOMER EXPERIENCED A SIGNAL LOSS AND WAS UNABLE TO OBTAIN READINGS AND RECEIVE GLUCOSE ALARMS. AS A RESULT, THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL, EXPERIENCED SEIZURES AND A LOSS OF CONSCIOUSNESS, AND WAS ABLE TO SELF-TREAT (UNSPECIFIED). NO THIRD-PARTY TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Convulsion/Seizure; Loss of consciousness

  MAUDE report 19388186 ↗
• InjuryMay 17, 2024Device Displays Incorrect Message; Application Program Problem; Device Displays Incorrect Message; Application Program Problem

  A CUSTOMER REPORTED RECEIVING A SENSOR ERROR MESSAGE WITH THE ADC DEVICE IN USE IPHONE WITH IOS OPERATING SYSTEM VERSION 17.4.1. CUSTOMER RECEIVED A "REPLACE SENSOR" MESSAGE AND WAS UNABLE TO OBTAIN READINGS. AS A RESULT, THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP) WHO ADMINISTERED INSULIN INJECTION (DOSE/TYPE NOT SPECIFIED) FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 19342395 ↗
• InjuryMay 15, 2024Device Alarm System; Application Program Problem; Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ADC DEVICE IN USE WITH IPHONE 10 WITH IOS VERSION 17.3.1. THE LOW AND HIGH GLUCOSE ALARMS DID NOT SOUND AND CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS. THERE WAS NO REPORT OF TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 19321050 ↗
• InjuryMay 3, 2024Device Alarm System; Application Program Problem; Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ADC DEVICE IN USE WITH AN UNKNOWN PHONE WITH UNKNOWN OPERATING SYSTEM VERSION UNKNOWN. CUSTOMER EXPERIENCED A SIGNAL LOSS AND WAS UNABLE TO OBTAIN READINGS AND RECEIVE GLUCOSE ALARMS. AS A RESULT, CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL AND EXPERIENCED A LOSS OF CONSCIOUSNESS AND RECEIVED UNSPECIFIED TREATMENT BY A HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 19244173 ↗
• InjuryApr 1, 2024Device Alarm System; Application Program Problem; Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ADC DEVICE IN USE WITH AN IPHONE PHONE WITH IOS OPERATING SYSTEM VERSION 17.3.1. THE LOW AND HIGH GLUCOSE ALARMS DID NOT SOUND, AND CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS. NO FURTHER INFORMATION WAS PROVIDED AND TROUBLESHOOTING WAS INCOMPLETE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 19011279 ↗
• InjuryMar 15, 2024Communication or Transmission Problem; Communication or Transmission Problem

  ABBOTT DIABETES CARE (ADC) RECEIVED A MEDWATCH REPORT WHICH REPORTED THE FOLLOWING INFORMATION: IT WAS REPORTED BY THE CUSTOMER "I'VE BEEN EXPERIENCING SEVERAL PROBLEMS WITH THE FREESTYLE LIBRE 2 SYSTEM. SPECIFICALLY, THE ACCURACY OF THE SENSORS/SYSTEM IS NOT CLOSE TO WHAT ABBOTT LABS IS REPORTING THEIR ACCURACY TO BE. PART OF THE QUALITY/RELIABILITY/ACCURACY IS TRACEABLE TO THE SENSOR DEVICES THEMSELVES. OTHER PROBLEMS ARE TRACEABLE TO THE FREESTYLE LIBRE 2 APPLICATION THAT PATIENTS/CONSUMERS ARE INSTRUCTED TO INSTALL ON THEIR SMART PHONE(S). STILL OTHER PROBLEMS APPEAR TO BE COMBINED BETWEEN THE SENSOR DEVICES AND THE APP. FIRST, THE SENSOR I INSTALLED MOST RECENTLY HAS BEEN PROVIDING WILDLY VARIABLE READINGS THAT GENERATE FALSE ALARMS OF LOW BLOOD GLUCOSE READING; BY ITSELF, THIS CREATES MISTRUST IN THE FREESTYLE LIBRE SYSTEM CAUSING PATIENTS TO IGNORE THE WARNINGS WHEN THEY SHOULD HEED THEM (TYPE 2 / BETA ERROR). MY BLOOD GLUCOSE TESTS USING A METER AND A DROP OF BLOOD SHOWED THAT THE BG (BLOOD GLUCOSE) READING WAS NORMAL TO SLIGHTLY ELEVATED WHEN THE FREESTYLE LIBRE 2 SENSOR WAS WARNING THAT BG WAS DANGEROUSLY LOW. SECOND, THE SENSOR WOULD GIVE HIGHLY VARIABLE READINGS TAKEN I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913649 ↗
• InjuryMar 8, 2024Unable to Obtain Readings; Device Displays Incorrect Message; Application Program Problem; Unable to Obtain Readings; Device Displays Incorrect Message; Application Program Problem

  A "REPLACE SENSOR" ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE USING THE FREESTYLE LIBRE 2 APPLICATION ON THE CUSTOMER¿S IPHONE 13 WITH IOS OPERATING SYSTEM VERSION 17.2.1 AND THE CUSTOMER WAS UNABLE TO OBTAIN READINGS. THE CUSTOMER EXPERIENCED SEIZURE, AND NO THIRD-PARTY TREATMENT WAS REPORTED. NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Convulsion/Seizure

  MAUDE report 18864460 ↗
• InjuryFeb 22, 2024Device Alarm System; Application Program Problem; Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ADC DEVICE IPHONE XR PHONE WITH IOS OPERATING SYSTEM VERSION 17.2.1. CUSTOMER EXPERIENCED A SIGNAL LOSS AND WAS UNABLE TO OBTAIN READINGS AND RECEIVE GLUCOSE ALARMS. AS A RESULT, CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL AND EXPERIENCED HEADACHES, ASTHENIA, AND COLD SWEATS AND WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT OF SUGAR FROM A NON-HEALTHCARE PROVIDER. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Diaphoresis; Fatigue; Headache

  MAUDE report 18759376 ↗
• InjuryJan 4, 2024Device Alarm System; Device Alarm System

  ABBOTT DIABETES CARE RECEIVED A MEDWATCH REPORT WHICH REPORTED THE FOLLOWING INFORMATION: AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH UNKNOWN PHONE WITH UNKNOWN OPERATING SYSTEM VERSION. THE LOW AND HIGH GLUCOSE ALARMS DID NOT SOUND "SINCE APP UPDATE" AND CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. NO CONTACT INFORMATION WAS PROVIDED TO ADC; THEREFORE, ADC IS UNABLE TO ATTEMPT ANY FOLLOW UP ACTIVITIES RELATED TO THIS EVENT. 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 18443361 ↗
• InjuryDec 15, 2023Device Alarm System; Device Alarm System

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE SE PHONE WITH IOS OPERATING SYSTEM VERSION 16.5.1. THE LOW AND HIGH GLUCOSE ALARMS DID NOT SOUND AND CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS, "FELL AND FRACTURED LEG", AND WAS UNABLE TO SELF-TREAT, REQUIRING GOING TO THE HOSPITAL. AT THE HOSPITAL, A HEALTHCARE PROFESSIONAL PROVIDED UNSPECIFIED THIRD-PARTY TREATMENT FOR A DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 18333901 ↗
• InjuryDec 15, 2023Device Alarm System; Device Alarm System

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE SE PHONE WITH IOS OPERATING SYSTEM VERSION 16.5.1. THE LOW AND HIGH GLUCOSE ALARMS DID NOT SOUND AND CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS, AND WAS UNABLE TO SELF-TREAT, REQUIRING THIRD-PARTY TREATMENT OF "RE-SUGARED" BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 18333868 ↗
• InjuryNov 29, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  AN ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE 13 PRO PHONE WITH IOS OPERATING SYSTEM VERSION 16.6.1. CUSTOMER RECEIVED A "SCAN ERROR" MESSAGE AND WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING BEING MOVED TO A BED AND PROVIDED WITH THIRD-PARTY TREATMENT OF "GLUCOSE TABLETS" (TYPE/DOSE UNSPECIFIED) BUT A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 18226652 ↗
• InjuryOct 12, 2023Device Alarm System; Application Program Problem; Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ADC DEVICE IN USE WITH IPHONE SE WITH IOS 15.6.1 (SYSTEM VERSION 2.7.3.3641). THE CUSTOMER EXPERIENCED A SIGNAL LOSS AND COULD NOT OBTAIN READINGS AND RECEIVE GLUCOSE ALARMS. AS A RESULT, THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL AND EXPERIENCED LOSS OF CONSCIOUSNESS HOWEVER, THERE WAS NO REPORT OF THIRD-PARTY MEDICAL INTERVENTION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 17922988 ↗