FreeStyle Libre 3 App 72075-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00357599816001), received between Oct 27, 2023 and Mar 2, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Application Program Problem” (19 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• 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, 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 ↗
• 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 ↗
• 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 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 ↗
• InjuryJun 5, 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 HUAWEI P20 PRO WITH ANDROID OPERATING SYSTEM VERSION 10. THE LOW GLUCOSE ALARM DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS SHAKING, FREEZING, A SEIZURE, AND UNABLE TO SPEAK. THE CUSTOMER WAS UNABLE TO SELF-TREAT, REQUIRING THIRD-PARTY ADMINISTRATION OF JUBIN SUGAR SOLUTION FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Convulsion/Seizure; Hypoglycemia; Shaking/Tremors

  MAUDE report 22150373 ↗
• InjuryMar 20, 2025Device Alarm System; Application Program Problem; Device Alarm System; Application Program Problem

  ABBOTT DIABETES CARE RECEIVED A MEDWATCH REPORT WHICH REPORTED THE FOLLOWING INFORMATION PERTAINING TO AN ABBOTT DIABETES CARE (ADC) DEVICE: THE CUSTOMER REPORTED ALARM WITH THE ADC DEVICE IN USE WITH UNKNOWN PHONE WITH ANDROID OPERATING SYSTEM VERSION. IT WAS REPORTED THAT THE CUSTOMER ENCOUNTERED A "LOSS OF SIGNAL" WHICH RESULTED IN THE TO THE DEVICE ALARMING. THE CUSTOMER DISABLED THE AUDIBLE ALARMS HOWEVER, THEY INDICATED THAT THE "SOFTWARE OVERRIDES ALL THE SETTING" RESULTING IN A CONTINUOUS ALARM. THERE WAS NO REPORT OF SELF-TREAT OR THIRD-PARTY MEDICAL TREATMENT PROVIDED FOR THE REPORTED ISSUE. 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 21657880 ↗
• InjuryJan 22, 2025Unable to Obtain Readings; Device Displays Incorrect Message; Unable to Obtain Readings; Device Displays Incorrect Message

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH SONY XPERIA 10 V WITH ANDROID OPERATING SYSTEM AND VERSION 14. 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. A FAMILY MEMBER CALLED THE EMERGENCY SERVICES AND UPON ARRIVAL, A HEALTHCARE PROFESSIONAL ADMINISTERED 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 21208801 ↗
• InjuryNov 14, 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 S23 ULTRA 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. AS A RESULT, THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS SEEN AT A HOSPITAL WHERE THEY WERE TREATED WITH INTRAVENOUS GLUCOSE FOR A DIAGNOSIS OF HYPOGLYCEMIA. THE CUSTOMER REPORTED THAT THEY WERE HOSPITALIZED UNTIL (B)(6) 2024. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 20683031 ↗
• InjuryOct 22, 2024Application Program Problem; Application Program Problem

  AN APPLICATION ISSUE WAS REPORTED WITH THE ADC DEVICE IN USE WITH XIAOMI REDMI 11S PHONE WITH ANDROID OPERATING SYSTEM VERSION 13 AND APP VERSION 3.6.0. THE CUSTOMER WAS UNABLE TO USE THEIR FREESTYLE LIBRE 3 APP DUE TO THEIR OPERATING SYSTEM NOT INCLUDED IN THE COMPATIBILITY LIST. AS A RESULT, CUSTOMER WAS UNABLE TO MONITOR GLUCOSE WITH SENSOR READINGS AND EXPERIENCED SYMPTOMS LOSS OF CONSCIOUSNESS, REQUIRING TREATMENT OF 12 OF INTRAVENOUS GLUCOSE BY HEALTHCARE PROFESSIONAL (HCP). IN ADDITION, A GLUCOSE READING OF 2.3 MMOL/L ON THE HCP METER WAS OBTAINED COMPARED TO A SENSOR READING OF 2.4 MMOL/L. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 20502086 ↗
• InjuryOct 14, 2024Unable to Obtain Readings; Device Displays Incorrect Message; Unable to Obtain Readings; Device Displays Incorrect Message

  AN UNKNOWN ERROR MESSAGE ISSUE WAS REPORTED WITH THE USE OF THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER WAS UNABLE TO OBTAIN AND MANAGE GLUCOSE LEVELS. THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS, AND WAS TREATED BY A NON-HEALTHCARE PROFESSIONAL WHO GAVE THE CUSTOMER COFFEE AND SUGAR TABLETS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 20446822 ↗
• InjuryOct 9, 2024Application Program Problem; Application Program Problem

  A CUSTOMER REPORTED AN INCOMPATIBLE OPERATING SYSTEM ISSUE WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH A SAMSUNG GALAXY A54 5G PHONE WITH ANDROID OPERATING SYSTEM VERSION 14. AS A RESULT, THE CUSTOMER WAS UNABLE TO USE THE APPLICATION AND EXPERIENCED A LOSS OF CONSCIOUSNESS. THE CUSTOMER SELF-TREATED WITH BANANA AND ORANGE JUICE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 20413279 ↗
• InjuryOct 8, 2024Unable to Obtain Readings; Communication or Transmission Problem; Unable to Obtain Readings; Communication or Transmission Problem

  A COMMUNICATION ERROR ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH CORSERA DURAFORCE PHONE WITH ANDROID OPERATING SYSTEM VERSION 12. THE CUSTOMER WAS UNABLE TO ACCESS THEIR FREESTYLE LIBRE 3 ACCOUNT DUE PHONE INCOMPATIBLE WITH THE APPLICATION. AS A RESULT, THE CUSTOMER WAS UNABLE TO MONITOR GLUCOSE WITH SENSOR READINGS AND EXPERIENCED SYMPTOMS OF "SWEATING, A SEIZURE AND A LOSS OF CONSCIOUSNESS, REQUIRING TREATMENT OF GLUCOSE BY A NON-HEALTHCARE PROFESSIONAL. EMERGENCY SERVICE WERE CALLED, UPON ARRIVAL THE PARAMEDIC ADMINISTERED DEXTROSE INTRAVENOUSLY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 20398651 ↗
• InjurySep 24, 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 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 SWEATING AND WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT OF AN "OKLUKO" INJECTION BY HEALTHCARE PROFESSIONAL (FRIEND). THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Diaphoresis; Hypoglycemia

  MAUDE report 20295810 ↗
• InjurySep 20, 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 AND UNKNOWN VERSION. THE CUSTOMER REPORTED THAT THE SENSOR FAILED TO ALARM WHEN THEIR GLUCOSE LEVEL WAS LOW. THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS LOSS OF CONSCIOUSNESS, "SWEATING A LOT", DIZZINESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS PROVIDED WITH ORANGE JUICE 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: Diaphoresis; Dizziness; Hypoglycemia; Loss of consciousness

  MAUDE report 20274323 ↗
• InjurySep 5, 2024Device Alarm System; Device Alarm System

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH SAMSUNG GALAXY PHONE WITH ANDROID OPERATING SYSTEM VERSION 14. 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 SYMPTOMS DESCRIBED AS "FEELING LOW" AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT OF CHOCOLATE 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 20148330 ↗
• InjuryAug 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 SAMSUNG GALAXY S23 WITH ANDROID OPERATING SYSTEM VERSION 14. 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 HYPOGLYCEMIA AND A LOSS OF CONSCIOUSNESS HOWEVER, WAS ABLE TO SELF-TREAT WITH A SOFT DRINK AND THERE WAS NO THIRD PARTY TREATMENT REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 20030650 ↗
• InjuryJul 3, 2024Application Program Problem; Compatibility Problem; Application Program Problem; Compatibility Problem

  A COMPATIBILITY ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) FREESTYLE LIBRE 3 APPLICATION IN USE WITH A SAMSUNG GALAXY S25 PHONE AND ANDROID OPERATING SYSTEM VERSION UNKNOWN. AS A RESULT, CUSTOMER EXPERIENCED A SEIZURE, AND NO THIRD-PARTY TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Convulsion/Seizure

  MAUDE report 19669973 ↗
• InjuryMay 23, 2024Unable to Obtain Readings; Application Program Problem; Unable to Obtain Readings; Application Program Problem

  A COMPATIBILITY ISSUE WAS REPORTED WITH AN ABBOTT DIABETES CARE (ADC) APPLICATION IN USE WITH A SAMSUNG GALAXY S9 PHONE WITH ANDROID VERSION 8.0.0 OPERATING SYSTEM. AS A RESULT, CUSTOMER EXPERIENCED A SEIZURE, "FELT LIGHTHEADED ALL OF A SUDDEN (KIND OF LIKE AN ANXIETY FEELING)", "STARTING GET SUSPICIOUS", "STARTED TALKING DIFFERENTLY", "FALLING", AND WAS UNABLE TO SELF-TREAT, REQUIRING THIRD-PARTY TREATMENT OF "ORANGE JUICE" BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Cognitive Changes; Convulsion/Seizure; Dizziness; Hypoglycemia

  MAUDE report 19379679 ↗
• InjuryMay 10, 2024Device 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 SAMSUNG A23 PHONE WITH ANDROID VERSION 14 OPERATING SYSTEM. CUSTOMER EXPERIENCED A SIGNAL LOSS AND WAS UNABLE TO RECEIVE GLUCOSE ALARMS. AS A RESULT, CUSTOMER EXPERIENCED "VERTIGO", "HEAD TURNING" AND WAS UNABLE TO SELF-TREAT, REQUIRING THIRD-PARTY TREATMENT OF "FRUIT JUICE" BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Dizziness; Hypoglycemia

  MAUDE report 19284457 ↗
• InjuryApr 23, 2024Application Program Problem; Application Program Problem

  AN INCOMPATIBILITY ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) APPLICATION, IN USE WITH AN UNSPECIFIED PHONE. AS A RESULT, THE CUSTOMER WAS UNABLE TO CHECK GLUCOSE AND EXPERIENCED A SEIZURE HOWEVER, THE CUSTOMER WAS ABLE TO SELF TREAT WITH "FAST ACTING" INSULIN PROVIDED BY A NON-HEALTHCARE PROFESSIONAL. THE CUSTOMER THEN HAD A CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP) WHO OBTAINED A BLOOD GLUCOSE RESULT OF 286 MG/DL BUT NO TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Convulsion/Seizure; Hyperglycemia

  MAUDE report 19165383 ↗
• InjuryMar 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 A SAMSUNG GALAXY S23 ULTRA WITH ANDROID OPERATING SYSTEM VERSION 14. THE CUSTOMER EXPERIENCED A SIGNAL LOSS AND WAS DELAYED TO OBTAIN READINGS AND RECEIVE GLUCOSE ALARMS. AS A RESULT, THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL AND REPORTED EXPERIENCING LOSS OF CONSCIOUSNESS WAS UNABLE TO SELF-TREAT HOWEVER, 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 18986126 ↗
• InjuryOct 27, 2023Unable to Obtain Readings; Application Program Problem; Unable to Obtain Readings; Application Program Problem

  CUSTOMER REPORTED THAT THEY ¿CANNOT START SENSOR¿ IN USE WITH GOOGLE PLUS 1 WITH ANDROID OPERATING SYSTEM VERSION 12 , APP VERSION 3.4.2.9593. AS A RESULT, THE CUSTOMER WAS UNABLE TO MONITOR GLUCOSE WITH SENSOR READINGS AND EXPERIENCED SYMPTOMS OF FREQUENT URINATION, THIRST, BLURRY VISION, LIGHTHEADED, ACHES, AND PAIN REQUIRING TREATMENT OF INSULIN DRIP PROVIDED BY A HEALTHCARE PROFESSIONAL FOR A DIAGNOSIS OF DIABETIC KETOACIDOSIS (DKA). AN HCP METER READING OF 1173 MG/DL WAS ALSO OBTAINED, THE TIME OF THIS READING WAS UNSPECIFIED IN RELATION TO THE MEDICAL EVENT. CUSTOMER FURTHER REPORTED THEY ¿BEEN TO THE HOSPITAL 20 TIMES IN THE LAST 14 MONTHS DUE TO KETOACIDOSIS¿. IT WAS NOT DIRECTLY RELATED TO BEING UNABLE TO START THE SENSOR. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Blurred Vision; Dizziness; Elevated Ketones/ Diabetic Ketoacidosis; Pain; Polydipsia

  MAUDE report 18022868 ↗