FreeStyle LibreLink 71732-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 00357599000042), received between Aug 26, 2019 and Sep 2, 2026 — classified as 109 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (88 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50556703 ↗
• InjuryJul 5, 2026Application Program Problem

  AN UNSPECIFIED ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH A SAMSUNG PHONE 721B AND ANDROID OPERATING SYSTEM VERSION 2.13.1.11596. THE CUSTOMER REPORTED THAT DUE TO SIGNAL LOSS THEIR GLUCOSE LEVELS AND THEY WERE NOT ALERTED TO THE CHANGES IN THESE LEVELS. AS A RESULT, THE CUSTOMER LOST CONSCIOUSNESS. AFTER AN UNSPECIFIED AMOUNT OF TIME, THE CUSTOMER REGAINED CONSCIOUSNESS AND SELF-TREATED BY CONSUMING FOOD. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 25712207 ↗
• InjuryMar 31, 2026Application Program Problem

  AN INCOMPATIBLE APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH SAMSUNG A 53 6 B PHONE WITH ANDROID OPERATING SYSTEM AND VERSION 16. AS A RESULT, CUSTOMER WAS UNABLE TO MONITOR GLUCOSE READINGS AND NO GLUCOSE ALARMS. THE CUSTOMER EXPERIENCED ALMOST LOSING CONSCIOUSNESS, WAS UNABLE TO SELF-TREAT AND WAS ADMINISTERED A GLUCOSE INJECTION PROVIDED BY A THIRD-PARTY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 24749904 ↗
• InjuryFeb 18, 2026Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH AN HONOR MAGIC 7 PHONE WITH ANDROID OPERATING SYSTEM VERSION 15. THE LOW GLUCOSE ALARMS DID NOT SOUND, AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS, WAS UNABLE TO SELF-TREAT, AND RECEIVED SWEETENED WATER AND SWEETENED YOGURT PROVIDED 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 24379215 ↗
• InjuryNov 28, 2025Application Program Problem; Application Program Problem

  AN INCOMPATIBLE APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH SAMSUNG S921B WITH ANDROID OPERATING SYSTEM VERSION 16 AND APP VERSION 2.12.1.11476. AS A RESULT, CUSTOMER WAS UNABLE TO MONITOR GLUCOSE READINGS AND NO GLUCOSE ALARMS. THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS "VISCERALLY WHITE, TEMPERATURE 33 DEGREE CELSIUS", LOSS OF CONSCIOUSNESS, UNRESPONSIVE AND WAS UNABLE TO SELF-TREAT. AN AMBULANCE WAS CALLED AND RESPONDED, THE CUSTOMER WAS THEN PROVIDED WITH 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 23672267 ↗
• InjuryNov 24, 2025Device Alarm System; Device Alarm System

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH GOOGLE PIXEL 8A PHONE WITH ANDROID OPERATING SYSTEM VERSION 16. THE LOW GLUCOSE ALARM DID NOT SOUND, AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED SEIZURE. THE CUSTOMER WAS SEEN AT A HOSPITAL WHERE THEY WERE TREATED WITH UNSPECIFIED TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Convulsion/Seizure

  MAUDE report 23633384 ↗
• InjuryOct 27, 2025Application Program Problem; Application Program Problem

  AN INCOMPATIBLE APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH A SAMSUNG GALAXY A14 WITH ANDROID OPERATING SYSTEM VERSION 15. 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 SEIZURES AND A FALL, WHERE THEY BRUISED THEIR LEFT ELBOW WHILE CRAWLING. THE CUSTOMER WAS ABLE TO SELF-TREAT WITH FOOD. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Bruise/Contusion; Convulsion/Seizure; Hypoglycemia

  MAUDE report 23398034 ↗
• InjuryOct 27, 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 A26 WITH ANDROID OPERATING SYSTEM VERSION 15, APPLICATION VERSION 2.12.1.11476. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS ACCELERATED BREATHING, "EYES WIDE OPEN, OPENED ALL THE SHUTTERS IN THE HOUSE", AND BIT THEIR TONGUE. THE EMERGENCY SERVICES WERE CALLED AND THE CUSTOMER WAS TRANSPORTED TO A HOSPITAL. UPON ARRIVAL, THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP) AND RECEIVED UNSPECIFIED EXAMINATIONS AND A BLOOD GLUCOSE READING OF 55 MG/DL OBTAINED ON AN UNSPECIFIED BLOOD GLUCOSE DEVICE. THE CUSTOMER THEN RECEIVED HCP ADMINISTRATION OF 2 GLASSES OF ORANGE JUICE AND A GLUCOSE INFUSION FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 23392912 ↗
• InjuryOct 22, 2025Device Alarm System; Device Alarm System

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH AN 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 FELT ILL AND LOST CONSCIOUSNESS. THE CUSTOMER WAS ABLE TO SELF-TREAT BY DRINKING A BEVERAGE CONTAINING GLUCOSE (DOSE/TYPE UNSPECIFIED). THE CUSTOMER WAS ALSO GIVEN A DRINK BY A THIRD-PARTY TO RAISE THE GLUCOSE LEVEL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 23360387 ↗
• InjuryAug 15, 2025Unable to Obtain Readings; Device Displays Incorrect Message; Unable to Obtain Readings; Device Displays Incorrect Message

  A "REPLACE SENSOR" ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA SUCH AS SEIZURE, LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS TAKEN TO A HOSPITAL, WHERE A HEALTHCARE PROFESSIONAL ADMINISTERED GLUCOSE AND FLUIDS. PAIN RELIEF WAS PROVIDED, AND EFFORTS WERE MADE TO STABILIZE BLOOD GLUCOSE LEVELS. UNSPECIFIED INJECTIONS WERE ALSO GIVEN AS PART OF THE TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 22822416 ↗
• InjuryMar 11, 2025Application Program Problem; Application Program Problem

  A CUSTOMER REPORTED A MISSING LOW ALARM ISSUE WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH A SAMSUNG GALAXY A34 WITH ANDROID OPERATING SYSTEM VERSION 212011314. AS A RESULT, THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND RECEIVED UNKNOWN TREATMENT FROM A HEALTHCARE PROFESSIONAL (HCP). THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 21574218 ↗
• InjuryJan 30, 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 A54 WITH ANDROID OPERATING SYSTEM VERSION 14. A CAREGIVER REPORTED RECEIVING A SIGNAL LOSS AND WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED SWEATING, "FEELING SLEEPY AND COULDN'T REMEMBER ANYTHING", LOSS OF CONSCIOUSNESS, AND WAS UNABLE TO SELF-TREAT. THE CAREGIVER CALLED A HEALTHCARE PROFESSIONAL, WHO ADVISED THEM TO PROVIDE THE CUSTOMER "A CAN OF COKE, JELLYBABIES (SWEETS), AND TWO PIECES OF BREAD AND BUTTER" AS TREATMENT, WHICH THE CAREGIVER DID. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 21273973 ↗
• InjuryJan 14, 2025Unable to Obtain Readings; Application Program Problem; Unable to Obtain Readings; Application Program Problem

  A CUSTOMER REPORTED AN INCOMPATIBLE OPERATING SYSTEM ISSUE WHERE THE LOW ALARM DOES NOT SOUND ON THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH AN HONOR MAGIC6 LITE PHONE WITH ANDROID OPERATING SYSTEM VERSION 2.11.2.11107. AS A RESULT, THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER REQUIRED ADMINISTRATION OF HONEY BY A NON-HEALTHCARE PROFESSIONAL (NON-HCP). ADDITIONALLY, THE CUSTOMER RECEIVED A GLUCOSE INJECTION FROM A HEALTHCARE PROFESSIONAL (HCP). THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 21148490 ↗
• InjuryDec 4, 2024Unable 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) WITH A MOTOROLA G30 WITH AN ANDROID OPERATING SYSTEM VERSION 12. 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 WAS GIVEN SWEETS AND COKE BY THEIR CAREGIVER. AN AMBULANCE WAS CALLED BUT WHEN HCP ARRIVED NO TREATMENT WAS PROVIDED AS THE PATIENT HAD ALREADY RECOVERED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 20846422 ↗
• InjuryDec 3, 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 SAMSUNG GALAXY S10 PHONE WITH ANDROID OPERATING SYSTEM VERSION 12. THE LOW GLUCOSE ALARM DID NOT SOUND, AND THE CUSTOMER WAS NOT ALERTED TO CHANGES IN GLUCOSE LEVELS. AS A RESULT, THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS, WHICH LED TO A FALL AND HEAD INJURY. THIS RESULTED IN A CUT/TEAR IN THE SKIN ON THEIR HEAD. THE CUSTOMER WAS SEEN AT A HOSPITAL WHERE THEY UNDERWENT A HEAD CT SCAN, LUNG ULTRASOUND, AND COMPLETE MORPHOLOGY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 20832980 ↗
• InjuryDec 2, 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 SAMSUNG A40 PHONE WITH ANDROID OPERATING SYSTEM VERSION 11 AND APP VERSION 2.11.2.11107. 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 DIZZINESS, A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT OF GLUCOSE GEL BY NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Dizziness; Hypoglycemia; Loss of consciousness

  MAUDE report 20820896 ↗
• InjuryNov 27, 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 UNKNOWN PHONE WITH ANDROID OPERATING SYSTEM VERSION 13.2 AND APP VERSION2.11.2.11107. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE DROPPED AND A FAMILY MEMBER CALLED EMERGENCY SERVICES. THE CUSTOMER WAS UNABLE TO SELF-TREAT, REQUIRING DEXTROSE CAPSULES PROVIDED BY NON-HEALTHCARE PROFESSIONAL AND GLUCAGON INJECTION ADMINISTERED BY 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

  MAUDE report 20798808 ↗
• InjuryNov 26, 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 SAMSUNG PHONE WITH ANDROID OPERATING SYSTEM VERSION 14. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED SWEATING AND WAS UNABLE TO SELF-TREAT, REQUIRING SUGAR AND FRUIT JUICE PROVIDED BY NON-HEALTHCARE PROFESSIONAL FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Diaphoresis; Hypoglycemia

  MAUDE report 20780058 ↗
• InjuryNov 22, 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 HUAWEI HRY LX1 PHONE WITH ANDROID OPERATING SYSTEM VERSION 10. THE HEALTHCARE PROFESSIONAL REPORTED THAT A CUSTOMER EXPERIENCED A SIGNAL LOSS AND WAS UNABLE TO RECEIVE HIGH GLUCOSE ALARMS. AS A RESULT, THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL AND EXPERIENCED LOSS OF CONSCIOUSNESS. IT WAS UNKNOWN IF THE CUSTOMER WAS ABLE TO SELF-TREAT. NO THIRD-PARTY TREATMENT WAS GIVEN. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 20756585 ↗
• InjuryNov 21, 2024Device Alarm System; Unable to Obtain Readings; Device Alarm System; Unable to Obtain Readings

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH A MOTOROLA PHONE WITH ANDROID OPERATING SYSTEM VERSION UNKNOWN. THE CUSTOMER EXPERIENCED A SIGNAL LOSS AND WAS UNABLE TO RECEIVE GLUCOSE ALARMS. IT WAS REPORTED THAT THE CUSTOMER NOTICED A "RED TRIANGLE SAYING NO ALARMS AVAILABLE" ON THE DEVICE. AS A RESULT, THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL AND EXPERIENCED LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS ABLE TO SELF-TREAT WITH COLA AND COOKIES UPON WAKING UP. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 20751748 ↗
• InjuryNov 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 WITH SAMSUNG SE PHONE WITH ANDROID OPERATING SYSTEM VERSION 12 AND APP VERSION 2.11.2.11107. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED "HOT FLUSH, PALENESS, FATIGUE AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS SEEN AT A HOSPITAL WHERE THEY WERE TREATED WITH SUGAR BY A HEALTHCARE PROFESSIONAL WITH A DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Fatigue; Hot Flashes/Flushes; Hypoglycemia; Loss of consciousness

  MAUDE report 20706898 ↗
• InjuryNov 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 WITH SAMSUNG SE PHONE WITH ANDROID OPERATING SYSTEM VERSION 12 AND APP VERSION 2.11.2.11107. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED "HOT FLUSH, PALENESS, FATIGUE AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS SEEN AT A HOSPITAL WHERE THEY WERE TREATED WITH SUGAR BY A HEALTHCARE PROFESSIONAL WITH A DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Fatigue; Hot Flashes/Flushes; Hypoglycemia; Loss of consciousness

  MAUDE report 20706824 ↗
• InjuryNov 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 WITH SAMSUNG SE PHONE WITH ANDROID OPERATING SYSTEM VERSION 12 AND APP VERSION 2.11.2.11107. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED "HOT FLUSH, PALENESS, FATIGUE AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS SEEN AT A HOSPITAL WHERE THEY WERE TREATED WITH SUGAR BY A HEALTHCARE PROFESSIONAL WITH A DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Fatigue; Hot Flashes/Flushes; Hypoglycemia; Loss of consciousness

  MAUDE report 20706727 ↗
• InjuryNov 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 WITH SAMSUNG SE PHONE WITH ANDROID OPERATING SYSTEM VERSION 12 AND APP VERSION 2.11.2.11107. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED "HOT FLUSH, PALENESS, FATIGUE AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS SEEN AT A HOSPITAL WHERE THEY WERE TREATED WITH SUGAR BY A HEALTHCARE PROFESSIONAL WITH A DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Fatigue; Hot Flashes/Flushes; Hypoglycemia; Loss of consciousness

  MAUDE report 20706620 ↗
• InjuryNov 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 WITH SAMSUNG SE PHONE WITH ANDROID OPERATING SYSTEM VERSION 12. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED "HOT FLUSH, PALENESS, FATIGUE AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS SEEN AT A HOSPITAL WHERE THEY WERE TREATED WITH SUGAR BY A HEALTHCARE PROFESSIONAL WITH A DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Fatigue; Hot Flashes/Flushes; Hypoglycemia; Loss of consciousness

  MAUDE report 20706552 ↗

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