FreeStyle Libre 2 AppRecalls & reported problems across all models

We found 2 models of FreeStyle Libre 2 App by Abbott Diabetes Care Inc in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2023 and Jun 19, 2025 — classified as 24 injuries.

The most frequently reported specific device problem is “Application Program Problem” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported FreeStyle Libre 2 App problems

FreeStyle Libre 2 App models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FreeStyle Libre 2 App 71926-01

  Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
  21 reports
• FreeStyle Libre 2 App 71857-01

  System, test, blood glucose, over the counter
  3 reports

Recent FreeStyle Libre 2 App adverse event reports

The 15 most recent reports across all models, 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Other Abbott Diabetes Care Inc products

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