LibreLinkUp 72154-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00357599824006), received between Jun 19, 2024 and Nov 25, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Application Program Problem” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Application Program Problem; Application Program Problem

  A COMPLAINT VIA EMAIL WAS RECEIVED. AN APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH AN UNKNOWN PHONE WITH AN IOS OPERATING SYSTEM VERSION. THE CUSTOMER INDICATED THAT THE LIBRELINKUP APPLICATION SEEMS TO NOT BE WORKING AT ALL ON IOS. IT APPEARS THAT THIS ISSUE STARTED RIGHT AFTER UPGRADING THE PHONE AND WATCH TO VERSION 26.1. AS A RESULT, THE CUSTOMER WAS UNABLE TO MONITOR GLUCOSE USING SENSOR READINGS AND EXPERIENCED A LOSS OF CONSCIOUSNESS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 23646770 ↗
• InjuryNov 15, 2024Application Program Problem; Application Program Problem

  AN UNEXPECTED APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) APPLICATION, IN USE WITH IPHONE XR WITH IOS OPERATING SYSTEM VERSION 17.6.1. THE CUSTOMER'S FREESTYLE LIBRELINKUP APPLICATION WAS "NOT RECEIVING INFORMATION" FROM FREESTYLE LIBRE 3 APPLICATION. AS A RESULT, THE CAREGIVER WAS NOT NOTIFIED VIA THE FREESTYLE LIBRELINKUP APPLICATION OF CUSTOMER'S GLYCEMIC STATUS. THE CUSTOMER EXPERIENCED CONFUSION, CONVULSIONS, SEIZURE AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER RECEIVED ORAL GLUCOSE FROM A FAMILY MEMBER AND JUICE FROM A HEALTHCARE PROFESSIONAL AS TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Confusion/ Disorientation; Convulsion/Seizure; Hypoglycemia

  MAUDE report 20695895 ↗
• InjuryJun 25, 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 17.2.1. 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 "SCREAMING, SLEEPING", A SEIZURE AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER RECEIVED TREATMENT OF HONEY, SUGAR AND GLUCAGON INJECTION PROVIDED BY A NON-HEALTHCARE PROFESSIONAL (CAREGIVER). THE CAREGIVER REPORTED CALLING EMERGENCY SERVICES BUT IT IS UNKNOWN IF THEY ADMINISTERED ANY ADDITIONAL MEDICAL TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Convulsion/Seizure; Hypoglycemia; Loss of consciousness

  MAUDE report 19605595 ↗
• InjuryJun 19, 2024Application Program Problem; Application Program Problem

  AN EMAIL COMPLAINT WAS RECEIVED IN WHICH AN UNEXPECTED APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) APPLICATION, IN USE WITH NOTHING PHONE 1 WITH ANDROID OPERATING SYSTEM VERSION 13. THE CUSTOMER'S FREESTYLE LIBRELINKUP APPLICATION WAS SHOWING "UNEXPECTED APPLICATION ERROR" MESSAGE. THE CAREGIVER WAS UNSURE WHETHER THE OTHER USER OF THE SAME ACCOUNT TURNED OFF THEIR NOTIFICATIONS OR ACKNOWLEDGED THE ALERT WITHOUT TAKING ACTION, AND IF THIS AFFECTED THE MAIN USER'S APPLICATION. AS A RESULT, THE CAREGIVER WAS NOT NOTIFIED VIA THE LINKUP APPLICATION OF CUSTOMER'S GLYCEMIC STATUS. THE CUSTOMER EXPERIENCED HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. THIS LED THEM BEING TAKEN TO A HOSPITAL, WHERE THEY WERE DIAGNOSED WITH OBSTRUCTIVE SLEEP APNEA, REPORTEDLY RESULTED "BRAIN DAMAGE" AND RECEIVED UNSPECIFIED TREATMENT BY A HEALTHCARE PROFESSIONAL (HCP). HCP SUSPECTED THAT THIS MIGHT HAVE BEEN CAUSED BY THE HYPOGLYCEMIA, BUT THEY COULD NOT CONFIRM A DIRECT LINK. AT THE SAME TIME, THEY WERE UNABLE TO DETERMINE ANY OTHER SPECIFIC CAUSE FOR THE SLEEP APNEA AND "BRAIN DAMAGE". THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Brain Injury; Hypoglycemia; Loss of consciousness

  MAUDE report 19570435 ↗