FreeStyle Libre 3 AppRecalls & reported problems across all models

We found 2 models of FreeStyle Libre 3 App by Abbott Diabetes Care Inc in the FDA's device registry (GUDID). Together they are named in 64 adverse event reports in the FDA's MAUDE database, received between Sep 6, 2023 and Mar 9, 2026 — classified as 64 injuries.

The most frequently reported specific device problem is “Application Program Problem” (55 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

FreeStyle Libre 3 App recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 9, 2023Completed

   If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.

   Z-0734-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported FreeStyle Libre 3 App problems

FreeStyle Libre 3 App models

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

• FreeStyle Libre 3 App 72075-01

  Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
  1 recall23 reports
• FreeStyle Libre 3 App 72077-01

  Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
  41 reports

Recent FreeStyle Libre 3 App adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Application Program Problem

  ABBOTT DIABETES CARE RECEIVED A MEDWATCH REPORT WHICH REPORTED THE FOLLOWING INFORMATION PERTAINING TO AN ABBOTT DIABETES CARE (ADC) DEVICE: A CUSTOMER REPORTED THAT THEIR PHONE HAS INCOMPATIBLE OPERATING SYSTEM VERSION. IN ADDITION, THE CUSTOMER SUGGESTED THAT THE URGENT LOW GLUCOSE ALARM SHOULD ALSO BE INCLUDED ON THE ADC READER AND MENTIONED THAT THE INFORMATION ON THE WEBSITE SHOULD BE MORE SPECIFIC, ESPECIALLY ON THE URGENT LOW GLUCOSE ALARM. THERE WAS NO REPORT OF ANY SELF OR THIRD-PARTY MEDICAL TREATMENT. ADC CUSTOMER SERVICE WAS ABLE TO REACH THE CUSTOMER AND WAS ABLE TO PROVIDE INFORMATION ABOUT THE URGENT LOW GLUCOSE ALARM FUNCTIONALITY. 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 24551968 ↗
• InjuryMar 2, 2026Application Program Problem

  A CUSTOMER REPORTED AN INCOMPATIBLE OS ISSUE WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH SAMSUNG GALAXY Z FLIP 5 WITH ANDROID OPERATING SYSTEM VERSION 3.6.6.12977. DUE TO THIS, THE CUSTOMER WAS UNABLE TO RECEIVE LOW GLUCOSE ALARMS AND THE CUSTOMER EXPERIENCED "POURING" SWEAT, FEELING FREEZING COLD, INABILITY TO WALK, AND IMPAIRED VISION. AS A RESULT, THE CUSTOMER WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT OF A QUART OF ORANGE JUICE, AND A BURRITO BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Blurred Vision; Diaphoresis; Hypoglycemia

  MAUDE report 24489330 ↗
• InjuryFeb 18, 2026Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE 16E WITH IOS OPERATING SYSTEM VERSION 26.2.1. A CUSTOMER REPORTED RECEIVING A SIGNAL LOSS AND WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED UNSPECIFIED SYMPTOMS AND STATED THAT THE PARAMEDICS ARRIVED TO THE CUSTOMER'S HOME. THE CUSTOMER RECEIVED UNSPECIFIED THIRD-PARTY TREATMENT FROM THE PARAMEDICS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24377372 ↗
• InjuryFeb 18, 2026Application Program Problem

  AN UNEXPECTED APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH SAMSUNG GALAXY S25 ULTRA PHONE WITH ANDROID OPERATING SYSTEM VERSION 16. THE CUSTOMER WAS UNABLE TO MONITOR THEIR GLUCOSE LEVEL BECAUSE THEY ONLY RECEIVED A SINGLE LOW ALARM ALERT THROUGH LIBRE LINKUP CAREGIVER APPLICATION, BUT THE NOTIFICATIONS ARE BEING SENT TO THEIR SPOUSE ONLY. AS A RESULT, THE CUSTOMER'S SPOUSE CONTACTED 911 AFTER RECEIVING ALERTS INDICATING THE CUSTOMER'S BLOOD GLUCOSE LEVEL HAD FALLEN BELOW 60 MG/DL WHILE AT WORK. THE CUSTOMER REMAINED UNDER PARAMEDIC CARE FOR OVER 40 MINUTES, DURING WHICH TIME NO ALERT NOTIFICATIONS WERE RECEIVED ON THEIR ADC DEVICE. NO CLINICAL SYMPTOMS WERE REPORTED HOWEVER, CUSTOMER WAS UNABLE TO SELF-TREAT AND THE PROVIDED THIRD-PARTY TREATMENT WAS UNKNOWN. THE CUSTOMER WAS CONTACTED ON THREE SEPARATE OCCASIONS TO GAIN ADDITIONAL DETAILS REGARDING THIS EVENT; HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24377176 ↗
• InjuryJan 30, 2026Device Alarm System; Computer Operating System Problem; Loss of Data

  ABBOTT DIABETES CARE (ADC) RECEIVED A MEDWATCH REPORT WHICH REPORTED THE FOLLOWING INFORMATION: THE CUSTOMER REPORTED RECEIVING AN UNEXPECTED LOW GLUCOSE ALARM ON THE ADC DEVICE. THEY INDICATED THAT THEY ATTEMPTED TO LOWER THE ALARM THRESHOLD IN THE APPLICATION FROM 70 MG/DL TO 60 MG/DL TO PREVENT THE ALERT; HOWEVER, THE LOW GLUCOSE ALARM STILL TRIGGERED AT 69 MG/DL. THE CUSTOMER ALSO NOTED THAT THE ALARM EVENT WAS NOT RECORDED IN THE LOGBOOK AND THAT DISABLING THE LOW GLUCOSE ALARM FEATURE DID NOT RESOLVE THE ISSUE. ADC CUSTOMER SERVICE SUCCESSFULLY CONTACTED THE CUSTOMER, WHO LATER CONFIRMED THAT THEY RESOLVED THE ISSUE THROUGH THEIR OWN TROUBLESHOOTING AND REQUIRED NO FURTHER ASSISTANCE. THERE WAS NO REPORT OF ANY THIRD-PARTY TREATMENT. 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 24228023 ↗
• InjuryDec 22, 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) DEVICE: A CUSTOMER REPORTED THAT THEY TRIED THREE TIMES TO LINK THEIR IPHONE. THE CUSTOMER CALLED THE ADC CUSTOMER SERVICE AND WAS TOLD TO DOWNLOAD ANOTHER APP, WHICH STATED THAT IT WAS INCOMPATIBLE. THEY WERE ADVISED TO PUT A NEW SENSOR. THERE WAS NO REPORT OF ADVERSE HEATH IMPACT AND ANY SELF OR THIRD-PARTY MEDICAL TREATMENT. 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 23866654 ↗
• InjuryDec 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) DEVICE: A CUSTOMER REPORTED THAT THEY TRIED THREE TIMES TO LINK THEIR IPHONE. THE CUSTOMER CALLED THE ADC CUSTOMER SERVICE AND WAS TOLD TO DOWNLOAD ANOTHER APP, WHICH STATED THAT IT WAS INCOMPATIBLE. THEY WERE ADVISED TO PUT A NEW SENSOR. THERE WAS NO REPORT OF ADVERSE HEATH IMPACT AND ANY SELF OR THIRD-PARTY MEDICAL TREATMENT. 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 23850923 ↗
• InjuryDec 2, 2025Application Program Problem; Application Program Problem

  A COMPLAINT WAS RECEIVED VIA CHAT. A CUSTOMER REPORTED AN INCOMPATIBLE OPERATING SYSTEM ISSUE WHEN USING AN ABBOTT DIABETES CARE (ADC) DEVICE WITH A MOTOROLA G STYLUS RUNNING ANDROID VERSION 13. THE CUSTOMER STATED THAT THE HIGH GLUCOSE ALARM DID NOT ACTIVATE DURING THE NIGHT, EVEN THOUGH GLUCOSE READINGS WERE BETWEEN 450 MG/DL AND 500 MG/DL. IT IS UNKNOWN WHAT SYMPTOMS THE CUSTOMER EXPERIENCED; HOWEVER, THEY WERE ADVISED BY THEIR HEALTHCARE PROFESSIONAL TO GO TO THE EMERGENCY ROOM. FURTHERMORE, THE TYPE OF TREATMENT PROVIDED WHEN THE CUSTOMER SELF-PRESENTED TO THE EMERGENCY ROOM IS UNKNOWN. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23694405 ↗
• InjuryNov 3, 2025Application Program Problem; Application Program Problem

  AN INCOMPATIBLE APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE 12 WITH IOS OPERATING SYSTEM VERSION 18.6.2 WITH SOFTWARE VERSION 3.6.5.12633. AS A RESULT, CUSTOMER WAS UNABLE TO MONITOR GLUCOSE READINGS DUE TO THE DEVICE SHOWING SIGNAL LOSS AND NO GLUCOSE ALARMS. THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS IN THE MIDDLE OF THE STREET AND HIT THEIR FACE WITH SOMETHING AND PASSERSBY CALLED AMBULANCE FOR THEM. THE CUSTOMER RECEIVED UNSPECIFIED THIRD-PARTY TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 23454678 ↗
• InjuryNov 3, 2025Application Program Problem; Application Program Problem

  AN INCOMPATIBLE APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE 12 WITH IOS OPERATING SYSTEM AND VERSION 18.6.2. AS A RESULT, CUSTOMER WAS UNABLE TO MONITOR GLUCOSE READINGS DUE TO THE DEVICE SHOWING SIGNAL LOSS AND NO GLUCOSE ALARMS. THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS AND LATER ON WAS ABLE TO SELF-TREAT WITH UNSPECIFIED TREATMENT. NO THIRD-PARTY TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 23454155 ↗
• InjuryOct 15, 2025Application Program Problem; Application Program Problem

  AN ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) APPLICATION IN USE WITH UNKNOWN PHONE WITH UNKNOWN OPERATING SYSTEM AND VERSION. THE CUSTOMER WAS UNABLE TO ACCESS THE APPLICATION AND UNABLE TO MONITOR GLUCOSE READINGS DUE TO INCORRECT E-MAIL AND PASSWORD COMBINATION. AT THIS POINT, WITHOUT MEASURING THEIR BLOOD SUGAR, THE CUSTOMER BECAME UNRESPONSIVE AND THEIR SPOUSE CALLED THE EMERGENCY SERVICE. THE FIREFIGHTERS ARRIVED AND MEASURED THE CUSTOMER'S BLOOD GLUCOSE LEVEL AND OBTAINED A GLUCOSE READING OF 44 MG/DL FROM UNKNOWN DEVICE. THE FIREFIGHTERS PROVIDED THE CUSTOMER WITH JUICE AND A SANDWICH AS TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 23296666 ↗
• InjurySep 19, 2025Device Alarm System; Unable to Obtain Readings; Application Program Problem; Device Alarm System; Unable to Obtain Readings; Application Program Problem

  A CUSTOMER REPORTED NOT RECEIVING ALARMS AND READINGS WHILE USING THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH A SAMSUNG GALAXY A13 WITH ANDROID OPERATING SYSTEM VERSION 3.6.5.11962. AS A RESULT, THE CUSTOMER WAS UNABLE TO USE THE APPLICATION AND SUBSEQUENTLY EXPERIENCED SWEATING, WEAKNESS, AND LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND REQUIRED THIRD-PARTY TREATMENT. A NON-HEALTHCARE PROFESSIONAL ADMINISTERED SUGAR, AND A HEALTHCARE PROFESSIONAL (HCP) LATER ASSESSED THE CUSTOMER BY MEASURING BLOOD PRESSURE, HEART RATE, AND PERFORMING AN ECG.THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Diaphoresis; Fatigue; Hypoglycemia; Loss of consciousness

  MAUDE report 23100679 ↗
• InjuryAug 29, 2025Application Program Problem; Application Program Problem

  AN ISSUE WITH THE ABBOTT DIABETES CARE (ADC) APPLICATION WAS REPORTED. A CUSTOMER REPORTED THAT THEY ATTEMPTED TO SCAN A NEW SENSOR HOWEVER, THE APP LOGGED THEM OUT OF THEIR ACCOUNT AND WHEN THEY TRIED TO RESET THE PASSWORD, IT WAS UNSUCCESSFUL. THE CUSTOMER FURTHER REPORTED EXPERIENCING A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL WHO PROVIDED AN UNSPECIFIED TREATMENT FOR THE DIAGNOSIS OF HYPOGLYCEMIA. ADC CUSTOMER SERVICE WAS ABLE TO REACH THE CUSTOMER, WHO INDICATED THAT THEY WERE ¿NOT USING THE PASSWORD REQUIREMENTS¿ HOWEVER, THEY WERE LATER ABLE TO LOG BACK INTO THE APP. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 22925792 ↗
• InjuryAug 27, 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) DEVICE: A CUSTOMER REPORTED THAT AFTER UPDATING THEIR IPHONE TO 18.5, THE ADC APPLICATION "STOPPED WORKING RELIABLY". THE CUSTOMER FURTHER REPORTED THAT THE "APPLICATION GAVE NO WARNING THAT THE NEW IOS VERSION WAS UNSUPPORTED/INCOMPATIBLE" DURING THE UPDATE AND AS RESULT, THEY WERE UNABLE TO SCAN THEIR GLUCOSE OR RECONNECT. THERE WAS NO REPORT OF ADVERSE HEATH IMPACT AND ANY SELF OR THIRD-PARTY MEDICAL TREATMENT. 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 22908026 ↗
• InjuryAug 4, 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 SAMSUNG GALAXY A15 PHONE WITH ANDROID OPERATING SYSTEM VERSION 14 AND APP VERSION 3.6.4. 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 UNSPECIFIED SYMPTOMS AND WAS UNABLE TO SELF-TREAT. PARAMEDICS WERE CALLED TO ASSIST. NO FURTHER INFORMATION REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702229 ↗

Other Abbott Diabetes Care Inc products

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