FreeStyle Libre 3 App 72077-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00357599817008), received between Sep 6, 2023 and Mar 9, 2026 — classified as 41 injuries.

The most frequently reported specific device problem is “Application Program Problem” (36 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 25 most recent of 41 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 29, 2025Unable to Obtain Readings; Device Displays Incorrect Message; Application Program Problem; Unable to Obtain Readings; Device Displays Incorrect Message; Application Program Problem

  A SIGNAL LOSS WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE IOS OPERATING SYSTEM 18.4.1 AND THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS AND RECEIVE GLUCOSE ALARMS. AS A RESULT, THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL AND PRESENTED AT A MEDICAL FACILITY. UPON ARRIVAL, AN UNSPECIFIED READING WAS OBTAINED ON A HEALTHCARE PROFESSIONAL (HCP) METER AND THE CUSTOMER RECEIVED HCP ADMINISTRATION OF AN UNSPECIFIED INFUSION AS TREATMENT FOR THE DIAGNOSIS OF HYPERGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 22108991 ↗
• InjuryMay 23, 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 18.3.2. 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 DIZZINESS, CONFUSION, AND DISORIENTATION. THE CUSTOMER INITIALLY RECEIVED THIRD-PARTY ADMINISTRATION OF ORANGE JUICE AND FOOD TO RAISE THEIR GLUCOSE LEVELS; HOWEVER, THE CUSTOMER WAS STILL DISORIENTED AND PRESENTED AT AN EMERGENCY ROOM. UPON ARRIVAL, THE CUSTOMER RECEIVED AN UNSPECIFIED READING OBTAINED ON A LABORATORY RESULT AND FURTHER RECEIVED HEALTHCARE PROFESSIONAL (HCP) ADMINISTRATION OF UNSPECIFIED MEDICATION AS TREATMENT FOR THE DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Confusion/ Disorientation; Dizziness; Hypoglycemia

  MAUDE report 22078747 ↗
• InjuryApr 11, 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 14 PROMAX WITH IOS OPERATING SYSTEM VERSION 16.2. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED SWEATING, DISORIENTATION, LOSS OF CONSCIOUSNESS AND SEIZURE. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND A CAREGIVER PROVIDED THEM JUICE. AN AMBULANCE WAS CALLED AND THEY TRANSPORTED THE CUSTOMER TO A HOSPITAL, WHERE A BLOOD TEST WAS PERFORMED AND SALINE WAS ADMINISTERED 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: Confusion/ Disorientation; Convulsion/Seizure; Diaphoresis; Hypoglycemia; Loss of consciousness

  MAUDE report 21829167 ↗
• InjuryFeb 25, 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 WAS UNABLE TO SELF-TREAT. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL, WHO ADMINISTERED GLUCOSE INJECTION AS TREATMENT FOR A DIAGNOSIS OF HYPOGLYCEMIA. A LABORATORY BLOOD GLUCOSE READING OF "1.9 MG" WAS REPORTED, HOWEVER IT IS UNKNOWN WHEN THIS READING WAS OBTAINED IN RELATION TO THE REPORTED MEDICAL EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 21463439 ↗
• InjuryFeb 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A COMPLAINT WAS RECEIVED VIA SOCIAL MEDIA. AN ERRATIC READINGS ISSUE WAS REPORTED WITH USE OF THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER REPORTED "SENSOR SEND ME TO THE HOSPITAL BECAUSE IT DOESN¿T SEND ME LOW BLOOD SUGAR AT TIME, GIVE A FALSE ALARM AND FALSE RESULTS" AND NO TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 21401712 ↗
• InjuryJan 23, 2025Device Alarm System; Application Program Problem; Device Alarm System; Application Program Problem

  ABBOTT DIABETES CARE (ADC) RECEIVED A MEDWATCH REPORT WHICH REPORTED THE FOLLOWING INFORMATION: AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH AN IPHONE WITH AN UNKNOWN OPERATING SYSTEM. THE LOW GLUCOSE ALARM DID NOT SOUND, AND THE CUSTOMER WAS UNAWARE OF CHANGES IN GLUCOSE LEVELS AND EXPERIENCED HYPOGLYCEMIA. CUSTOMER¿S CAREGIVER STATED CUSTOMER¿S ¿GLUCOSE WAS UNDER 40¿ AND DID NOT GENERATE ALARMS THROUGH THE LIBRE FREESTYLE 3 APPLICATION AND ON LIBRE LINK UP APPLICATION. IT WAS FURTHER REPORTED THAT ¿AWARENESS OF THIS CAME FROM AN ALARM TO PARENTS IPHONE THAT THE DATA CONNECTION HAD DROPPED FOR 20 MINUTES OR MORE WHILE THE ALARM FOR HYPOGLYCEMIA HAD FAILED TO INITIATE FOR OVER AN HOUR ON PRIMARY DEVICE AND 3 SEPARATE DEVICES USING THE LINK UP APP.¿ CUSTOMER¿S CAREGIVER CONTACTED ABBOTT TO REPORT ISSUE AND STATED THEY WERE TOLD ¿THAT HAVING A PHONE USING THE LINK UP APP CLOSE TO THE PRIMARY USER¿S PHONE WOULD RESULT IN INTERFERENCE RESULTING IN NOT RECEIVING ALARMS.¿ NO THIRD-PARTY TREATMENT WAS REPORTED. ADC CUSTOMER SERVICE CONTACTED THE CUSTOMER, AND NO FURTHER EVENT INFORMATION WAS PROVIDED. CUSTOMER INDICATED THEY DO NOT RECALL IF THE PRODU

  Patient problems: Hypoglycemia

  MAUDE report 21219635 ↗
• InjuryJan 13, 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 CUSTOMER RECEIVED A SIGNAL LOSS AND WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER "FAINTED FOR A MOMENT" DUE TO HYPOGLYCEMIA, REQUIRING APPLE JUICE AND ORAL GLUCOSE PROVIDED BY A NON-HEALTHCARE PROFESSIONAL FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 21139722 ↗
• InjuryDec 10, 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 11 WITH IOS OPERATING SYSTEM VERSION 18.1. THE CUSTOMER RECEIVED A SIGNAL LOSS AND WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS "LACK OF CONTROL", DIZZINESS, SWEATING AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS TREATED WITH GLUCAGON SPRAY BY A NON-HEALTHCARE PROFESSIONAL FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Diaphoresis; Dizziness; Hypoglycemia

  MAUDE report 20888552 ↗
• InjuryNov 27, 2024Application Program Problem; Application Program Problem

  ABBOTT DIABETES CARE (ADC) RECEIVED A MEDWATCH REPORT WHICH REPORTED THE FOLLOWING INFORMATION: A CUSTOMER REPORTED THEIR ¿IPHONE WAS NOT COMPATIBLE WITH THE LIBRE 3 READER APP. THE INCOMPATIBILITY WAS CAUSED BY THE IOS VERSION ON MY PHONE, MY PHONE HAD A CURRENT VERSION OF IOS, AND THE LIBRE 3 READER APP WAS ONLY COMPATIBLE THROUGH SEVERAL EARLIER IOS VERSIONS.¿ NO THIRD-PARTY TREATMENT OR PATIENT CONSEQUENCES WERE REPORTED. ADC CUSTOMER SERVICE ATTEMPTED TO CONTACT THE CUSTOMER 3 TIMES TO GAIN ADDITIONAL DETAILS REGARDING THIS EVENT; HOWEVER, ALL FOLLOW UP ATTEMPTS WERE UNSUCCESSFUL. 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 20800546 ↗
• InjuryNov 18, 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) IN USE WITH AN IPHONE 15, IOS OPERATING SYSTEM VERSION 17.6.1, AND APPLICATION VERSION 3.6.1.11430. 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 GLUCOSE BY A NON-HEALTHCARE PROFESSIONAL AND A HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 20713321 ↗
• InjuryOct 23, 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 16. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED "DIABETIC COMA". THE CUSTOMER WAS SEEN BY A HEALTHCARE PROFESSIONAL AND WAS TREATED WITH GLUCOSE FOR A DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Coma; Hypoglycemia

  MAUDE report 20516771 ↗
• InjuryOct 22, 2024Application Program Problem; Application Program Problem

  ABBOTT DIABETES CARE (ADC) RECEIVED A MEDWATCH REPORT WHICH REPORTED THE FOLLOWING INFORMATION: AN APPLICATION ISSUE WAS REPORTED WITH THE ADC DEVICE IN USE WITH AN UNKNOWN PHONE, UNKNOWN OPERATING SYSTEM AND UNKNOWN APP VERSION. A CUSTOMER REPORTED THEIR ¿LIBRE 3 APP STOPPED WORKING¿ AND THEY ¿HAD TO LOG IN TO THE APP AND IT STARTED WORKING AGAIN BUT LOST ALL PREVIOUS INFORMATION¿. CUSTOMER FURTHER REPORTED THEY DID NOT HAVE ANY LOW OR HIGH BLOOD SUGAR OR ANY ALARMS. NO PATIENT CONSEQUENCES WERE REPORTED. 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 20509008 ↗
• InjuryOct 8, 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 8. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER HAD A GLUCOSE READING OF 19 MG/DL, THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP). THE HCP ADMINISTERED AN INTRAVENOUS DRIP WITH GLUCOSE WITH A DIAGNOSIS OF HYPOGLYCEMIA. A BLOOD GLUCOSE TEST OF 30 MG/DL WAS OBTAINED ON THE HEALTHCARE PROFESSIONAL METER AND CONTINUED TO RISE WITH TREATMENT. THE CUSTOMER WAS ADVISED TO STAY OVER NIGHT BUT REFUSED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 20399982 ↗
• InjurySep 27, 2024Unable to Obtain Readings; Application Program Problem; Unable to Obtain Readings; Application Program Problem

  AN INCOMPATIBILITY ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE PHONE WITH IOS OPERATING SYSTEM VERSION 11. THE CUSTOMER WAS UNABLE TO ACCESS THEIR FREESTYLE LIBRE 3 ACCOUNT DUE TO INCOMPATIBILITY. AS A RESULT, THE CUSTOMER WAS UNABLE TO MONITOR GLUCOSE WITH SENSOR READINGS AND EXPERIENCED A LOSS OF CONSCIOUSNESS, THE CUSTOMER WAS ABLE TO SELF-TREAT WITH JUICE AFTER THEY REGAINED CONSCIOUSNESS, THE CUSTOMER WAS ADDITIONALLY TREATED WITH ORAL GLUCOSE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 20321164 ↗
• InjurySep 9, 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 14 PLUS WITH IOS OPERATING SYSTEM VERSION 17.5.1. THE CUSTOMER RECEIVED A SIGNAL LOSS AND WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS, BUT WAS ABLE TO SELF-TREAT BY DRINKING JUICE 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 20170864 ↗