FreeStyle LibreLink 71733-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00357599000059), received between Apr 9, 2019 and Jun 2, 2026 — classified as 91 injuries, 1 malfunction.

The most frequently reported specific device problem is “Application Program Problem” (77 reports).

1 other recall cover devices cleared under the same FDA submission (P160030); they may or may not involve this specific model.

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 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2026Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE 15 WITH IOS OPERATING SYSTEM VERSION 26.4.2. A CUSTOMER REPORTED RECEIVING A SIGNAL LOSS AND WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED FAINTING, SHAKING, DROWSINESS, AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS TREATED WITH GLUCOSE SHOT AND THREE BOTTLES OF GLUCOSE AID. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness; Shaking/Tremors; Sleepiness/Drowsiness/Somnolence

  MAUDE report 25368922 ↗
• InjuryJun 2, 2026Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE 15 WITH IOS OPERATING SYSTEM VERSION 26.4.2. A CUSTOMER REPORTED RECEIVING A SIGNAL LOSS AND WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED FAINTING, SHAKING, DROWSINESS, AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS TREATED WITH GLUCOSE SHOT AND THREE BOTTLES OF GLUCOSE AID. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness; Shaking/Tremors; Sleepiness/Drowsiness/Somnolence

  MAUDE report 25368899 ↗
• InjuryJun 2, 2026Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE 15 WITH IOS OPERATING SYSTEM VERSION 26.4.2. A CUSTOMER REPORTED RECEIVING A SIGNAL LOSS AND WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED FAINTING, SHAKING, DROWSINESS, AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS TREATED WITH GLUCOSE SHOT AND THREE BOTTLES OF GLUCOSE AID. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness; Shaking/Tremors; Sleepiness/Drowsiness/Somnolence

  MAUDE report 25368898 ↗
• InjuryMay 26, 2026Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH SAMSUNG S24, ANDROID OPERATING SYSTEM AND VERSION 16. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS "NUMB HANDS, SHAKINESS OF HANDS" AND SELF-TREATED BY CONSUMING "JUICE, FOOD, SIRIPIRI GLUCOSE TABLETS, AND A CANDY". NO THIRD-PARTY TREATMENT WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Numbness; Shaking/Tremors

  MAUDE report 25284235 ↗
• InjuryMay 6, 2026Application Program Problem

  A SIGNAL LOSS ISSUE DUE TO AN INCOMPATIBLE OPERATING SYSTEM WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE USED WITH AN IPHONE (MODEL UNKNOWN) RUNNING IOS VERSION 2.13.1.9278. DUE TO THE INCOMPATIBLE CONFIGURATION, THE CUSTOMER DID NOT RECEIVE LOW GLUCOSE ALARMS. THE CUSTOMER REPORTED WEAKNESS AND SWEATING AND SELF-TREATED WITH GLUCOSE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Diaphoresis; Fatigue

  MAUDE report 25105301 ↗
• InjuryApr 23, 2026Application Program Problem

  AN UNSPECIFIED ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) APPLICATION IN USE ON AN UNKNOWN PHONE WITH AN UNKNOWN OPERATING SYSTEM AND VERSION. THE CUSTOMER INQUIRED ABOUT HOW TO INSTALL AND CONNECT TO THE LIBRELINK APP AND THE STEPS REQUIRED TO DO SO. THE CUSTOMER WAS UNABLE TO ACCESS THE FREESTYLE LIBRELINK APP DUE TO AN INCORRECT EMAIL AND PASSWORD COMBINATION. AS A RESULT, THE CUSTOMER WAS UNABLE TO MONITOR GLUCOSE READINGS. THE CUSTOMER EXPERIENCED DIZZINESS AND SELF-TREATED WITH A GLASS OF ORANGE JUICE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 24962123 ↗
• InjuryMar 30, 2026Application Program Problem

  AN INCOMPATIBLE APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE 7 WITH ANDROID OPERATING SYSTEM AND VERSION 15.8.5. AS A RESULT, CUSTOMER WAS UNABLE TO MONITOR GLUCOSE READINGS AND NO GLUCOSE ALARMS. THE CUSTOMER EXPERIENCED CONVULSIONS AND SEIZURE. AFTER AN HOUR, THE CUSTOMER WAS ABLE TO SELF-TREAT BY DRINKING "WATER WITH SUGAR". NO THIRD-PARTY TREATMENT WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Convulsion/Seizure; Hypoglycemia

  MAUDE report 24713850 ↗
• InjuryFeb 12, 2026Device Alarm System

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT UNKNOWN PHONE, OPERATING SYSTEM AND VERSION. 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 WAS UNABLE TO SELF-TREAT. ACCORDING TO THE CUSTOMER'S APPLICATION, THEIR BLOOD SUGAR WAS 50 MG/DL AND 52 MG/DL. THE CUSTOMER WAS THEN PROVIDED WITH POWDERED SUGAR AND A SUGARY DRINK (OASIS) BY A NON-HEALTHCARE PROFESSIONAL AS INITIAL TREATMENT. THE EMERGENCY SERVICES WAS CALLED AND UPON ARRIVAL, THE CUSTOMER'S BLOOD SUGAR WAS MEASURED ON A CAPILLARY TEST AND IT SHOWED 33 MG/DL. THE CUSTOMER'S BODY TEMPERATURE HAD DROPPED TO 34 DEGREES CELSIUS, SO THEY TAKE THEM TO A HOSPITAL. THE CUSTOMER WAS GIVEN AN UNSPECIFIED INTRAVENOUS DRIP BY A HEALTHCARE PROFESSIONAL AS 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 24320159 ↗
• InjuryJan 9, 2026Application Program Problem

  AN APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH AN IPHONE 15 PRO WITH IOS OPERATING SYSTEM VERSION 26.1. THE CUSTOMER REPORTS THEY CANNOT SHARE DATA WITH THEIR CAREGIVER AND EXPERIENCED HYPOGLYCEMIA, A LOSS OF CONSCIOUSNESS AND REQUIRED MEDICAL ASSISTANCE; HOWEVER, NO TREATMENT DETAILS WERE PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 24030419 ↗
• InjuryDec 25, 2025Device Alarm System; Application Program Problem; Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) APPLICATION IN USE WITH AN IPHONE (UNKNOWN MODEL) WITH IOS OPERATING SYSTEM, VERSION 18.6.2. THE CUSTOMER EXPERIENCED A SIGNAL LOSS AND WAS UNABLE TO OBTAIN READINGS AND RECEIVE LOW GLUCOSE ALARM. AS A RESULT, THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL AND EXPERIENCED SYMPTOMS SUCH AS BLIND VISION, SHAKING, AND NEEDING TO HOLD ONTO SOMETHING TO AVOID FALLING, AS WELL AS AN INABILITY TO HEAR ANYTHING. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND REQUIRED UNSPECIFIED THIRD-PARTY TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Blurred Vision; Shaking/Tremors

  MAUDE report 23891932 ↗
• InjuryNov 27, 2025Unable to Obtain Readings; Application Program Problem; Unable to Obtain Readings; Application Program Problem

  AN "INCOMPATIBLE OS OR INCOMPATIBLE DEVICE" ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) IN USE WITH AN IPHONE 15, IOS OPERATING SYSTEM VERSION 18.6.2, AND APPLICATION VERSION 2.12.2.8979. THE CUSTOMER REPORTED THAT THEIR APP HAD A "SIGNAL LOSS" WITH THE SENSOR THEREFORE, THE CUSTOMER WAS NOT ALERTED OF CHANGES IN THEIR GLUCOSE LEVELS. THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER'S BLOOD GLUCOSE WAS MEASURED AND THEY WERE GIVEN GLUCOSE INFUSION BY A HEALTHCARE PROFESSIONAL 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 23665737 ↗
• InjuryNov 18, 2025Application Program Problem; Application Program Problem

  AN INCOMPATIBLE APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE 13 WITH IOS OPERATING SYSTEM AND VERSION 18.6.2. AS A RESULT, CUSTOMER WAS UNABLE TO MONITOR GLUCOSE READINGS DUE TO THE DEVICE SHOWING "CHECK SENSOR" AND NO GLUCOSE ALARMS. THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS. LATER ON, THE CUSTOMER WOKE UP AND SELF-TREATED WITH "JELLY BABIES". NO THIRD-PARTY TREATMENT WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 23580540 ↗
• InjuryOct 6, 2025Application Program Problem; Application Program Problem

  AN APPLICATION COMPATIBILITY ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH AN IPHONE (UNKNOWN MODEL) WITH IOS OPERATING SYSTEM VERSION 18.6.2 AND APP VERSION 2.12.2.8979. DUE TO THE REPORTED ISSUE, THE CUSTOMER DID NOT RECEIVE ALARMS, EXPERIENCED HYPOGLYCEMIA, A LOSS OF CONSCIOUSNESS, AND FELL WHICH RESULTED IN A HEAD INJURY. THE CUSTOMER WAS TAKEN TO THE HOSPITAL AND REPORTEDLY, TREATED THEIR HEAD AND ¿EVERYTHING WAS OKAY¿. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 23224988 ↗
• InjurySep 26, 2025Device Alarm System; Application Program Problem; Device Alarm System; Application Program Problem

  AN EMAIL COMPLAINT WAS RECEIVED IN WHICH AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH UNKNOWN PHONE, OPERATING SYSTEM AND VERSION. A HEALTHCARE PROFESSIONAL REPORTED THAT THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER HAD HYPOGLYCEMIA FOR 4 HOURS AND LOSS OF CONSCIOUSNESS. AN AMBULANCE WAS CALLED, BUT NO FURTHER INFORMATION WAS PROVIDED. THE ADC CUSTOMER SERVICE MADE THREE ATTEMPTS TO GATHER ADDITIONAL INFORMATION BUT WAS UNSUCCESSFUL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 23156382 ↗
• InjurySep 9, 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 WITH IOS OPERATING SYSTEM VERSION 18.6.2. 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. THE CUSTOMER WAS PROVIDED WITH GLUCAGEN INJECTION BY A HEALTHCARE PROFESSIONAL AND NON-HEALTHCARE PROFESSIONAL AS TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 23011617 ↗
• InjurySep 2, 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 UNKNOWN PHONE WITH UNKNOWN OPERATING SYSTEM. THE LOW GLUCOSE ALARM DID NOT SOUND, AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED SWEATING AND A LOSS OF CONSCIOUSNESS. AFTER AN UNSPECIFIED AMOUNT OF TIME, THE CUSTOMER WAS TREATED WITH GLUCAGON INJECTION AND FRUIT JUICE BY A NON-HEALTHCARE PROFESSIONAL (NON-HCP). THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Diaphoresis; Hypoglycemia; Loss of consciousness

  MAUDE report 22939568 ↗
• InjurySep 2, 2025Device Alarm System; Application Program Problem; Device Alarm System; Application Program Problem

  AN EMAIL COMPLAINT WAS RECEIVED IN WHICH AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH UNKNOWN PHONE WITH UNKNOWN OPERATING SYSTEM AND VERSION. 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. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL, THEY MEASURED A GLUCOSE READING OF 2.2 MMOL/L ON A HEALTHCARE PROFESSIONAL METER. THE PARAMEDICS THEN ADMINISTERED ORAL LIQUID GLUCOSE TO THE CUSTOMER AS TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 22938938 ↗
• InjurySep 2, 2025Application Program Problem; Application Program Problem

  AN ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) APPLICATION IN USE WITH UNKNOWN PHONE, UNKNOWN OPERATING SYSTEM AND VERSION. THE CUSTOMER WAS UNABLE TO ACCESS THE APPLICATION AND UNABLE TO MONITOR GLUCOSE READINGS DUE TO PASSWORD PROBLEM. AT THIS POINT, WITHOUT MEASURING THEIR BLOOD SUGAR, THE CUSTOMER SELF-INJECTED WITH TWO DOSES OF INSULIN (TYPE UNSPECIFIED). HOWEVER, THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS, FELL, AND WAS TAKEN TO A HOSPITAL. THE CUSTOMER UNDERWENT VARIOUS TESTS SUCH AS CT SCAN, BLOOD SAMPLE AND WAS PROVIDED UNSPECIFIED HEART MEDICINE, UNSPECIFIED INTRAVENOUS DRIP, AND INSULIN (TYPE/DOSE UNSPECIFIED) BY A HEALTHCARE PROFESSIONAL AS TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia; Loss of consciousness

  MAUDE report 22938597 ↗
• InjuryAug 27, 2025Device Alarm System; Application Program Problem; Device Alarm System; Application Program Problem

  A SOCIAL MEDIA COMPLAINT WAS RECEIVED. AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE WITH IOS OPERATING SYSTEM VERSION 1.1.0. THE LOW AND HIGH GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED UNSPECIFIED SYMPTOMS OF DIABETIC KETOACIDOSIS. SUBSEQUENTLY, THE CUSTOMER WAS SEEN AT A HOSPITAL AND TREATED WITH UNSPECIFIED TREATMENT FOR A DIAGNOSIS OF DKA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 22909845 ↗
• InjuryAug 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 2 PHONE WITH IOS OPERATING SYSTEM VERSION 2.12.1.8965. THE LOW AND HIGH GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED CONVULSION, REQUIRING TREATMENT OF ORAL GLUCOSE BY NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Convulsion/Seizure; Hypoglycemia

  MAUDE report 22729324 ↗
• InjuryJul 9, 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 UNKNOWN PHONE WITH UNKNOWN OPERATING SYSTEM VERSION 18.5. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED LOSS OF BALANCE AND UNABLE TO SELF-TREAT. THE CUSTOMER WAS PROVIDED WITH GLUCOSE INJECTION (TYPE/DOSE UNSPECIFIED) BY A THIRD-PARTY AS TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 22464824 ↗
• InjuryMay 22, 2025Application Program Problem; Application Program Problem

  A CUSTOMER PREVIOUSLY CONTACTED ABBOTT DIABETES CARE (ADC) TO REPORT THAT THEIR FREESTYLE LIBRELINK APPLICATION IN USE WITH IPHONE 16 WITH IOS OPERATING SYSTEM AND VERSION 18.4.1 WOULD NOT SCAN THE SENSORS. UPON TROUBLESHOOTING, IT WAS DETERMINED THAT THE CUSTOMER WAS USING AN INCOMPATIBLE OPERATING SYSTEM AND AN ORDER FOR A READER WAS PLACED FOR THE CUSTOMER. HOWEVER, THE CUSTOMER REPORTED THAT THERE WAS A DELIVERY DELAY WITH THE READER AND THEY HAD NO WAY TO MONITOR THEIR GLUCOSE. THE CUSTOMER WAS UNABLE TO TEST AND EXPERIENCED LOSS OF CONSCIOUSNESS DUE TO HYPOGLYCEMIC EVENT AND WAS UNABLE TO SELF-TREAT. A NON-HEALTHCARE PROFESSIONAL PROVIDED THEM WITH GLUCOGEL AS TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 22071361 ↗
• InjuryMay 13, 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 WITH IOS OPERATING SYSTEM VERSION 17.1.1. WITH SOFTWARE VERSION 2.12.0.8319. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED SWEATING, CONVULSIONS, AND LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND A HEALTHCARE PROFESSIONAL PROVIDED THEM SUGAR (ORAL) AS TREATMENT FOR A DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 22012520 ↗
• InjuryApr 1, 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 8 WITH IOS OPERATING SYSTEM AND VERSION 16.7.7. THE HIGH/LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED SWEATING, LOSS OF STRENGTH, AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS PROVIDED WITH COCA-COLA AND SWEET DRINK BY A NON-HEALTHCARE PROFESSIONAL FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Diaphoresis; Fatigue; Hypoglycemia

  MAUDE report 21741660 ↗
• InjuryJan 16, 2025Application Program Problem; Application Program Problem

  AN INCOMPATIBLE APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH AN IPHONE 15 PRO WITH IOS OPERATING SYSTEM VERSION 18.1.1. THE CUSTOMER STATED THE LOW GLUCOSE ALARM DID NOT APPEAR. AS A RESULT, THE CUSTOMER WAS UNABLE TO MONITOR GLUCOSE WITH SENSOR READINGS AND EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. A NON-HEALTHCARE PROFESSIONAL (HCP) PROVIDED RASPBERRY SYRUP AS TREATMENT AND THE CUSTOMER REGAINED CONSCIOUSNESS. THE EMERGENCY SERVICES WERE CALLED AND UPON ARRIVAL, A HEALTHCARE PROFESSIONAL ADMINISTERED SIX UNITS OF GLUCOSE INTRAVENOUSLY AS 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 21171224 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160030. One submission often covers many models, so check the product and lot details in each record.

• Z-1273-2023 · Feb 13, 2023 · Open, Classified
  FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System