FreeStyle Libre 14 day 71938Recalls & reported problems

Summary

The FDA's MAUDE database contains 578 adverse event reports that list this exact device (DI 00357599002008), received between Jan 4, 2019 and Oct 15, 2025 — classified as 105 injuries, 473 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (471 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 13, 2023Open, Classified

   Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.

   Z-1274-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 578 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Product Quality Problem; Product Quality Problem

  A CUSTOMER REPORTED AFTER REMOVING THE ABBOTT DIABETES CARE (ADC) DEVICE FROM THE AC ADAPTER AFTER APPROXIMATELY 1.5 HOURS OF CHARGING, THE DEVICE CAME INTO CONTACT WITH THE AREA JUST BELOW THEIR LEFT WRIST, RESULTING IN A BURN AND SCAR AT THE SITE. THE CUSTOMER EXPERIENCED PAIN, DISCOMFORT AND HAD CONTACT WITH A HEALTH CARE PROFESSIONAL (HCP) WHO PRESCRIBED AN UNSPECIFIED OINTMENT FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Burn(s); Discomfort; Pain

  MAUDE report 23293013 ↗
• MalfunctionAug 27, 2025Product Quality Problem; Product Quality Problem

  A CUSTOMER REPORTS THEIR ABBOTT DIABETES CARE DEVICE, "GET'S HOT" AND "STARTS TO SMOKE." THERE WAS NO REPORT OF FIRE, EXPLOSION, OR SHOCK. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906331 ↗
• MalfunctionJul 15, 2025Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADC DEVICE IS TOO HOT TO HOLD WHILE CHARGING. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. CUSTOMER REPORTS USING THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508428 ↗
• InjuryMay 20, 2025Premature Discharge of Battery; Unable to Obtain Readings; Premature Discharge of Battery; Unable to Obtain Readings

  A BATTERY/POWER ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS DUE TO A FAST-DRAINING BATTERY. AS A RESULT, THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS DUE TO HYPERGLYCEMIA. THE CUSTOMER CONTACTED A HEALTHCARE PROFESSIONAL (HCP), WHO MEASURED THE CUSTOMER'S BLOOD GLUCOSE WITH A RESULT OF 400 MG/DL FOR A DIAGNOSIS OF HYPERGLYCEMIA ON (B)(6) 2025 AND UNDERWENT SURGERY ON (B)(6) 2025. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia; Loss of consciousness

  MAUDE report 22056604 ↗
• InjuryApr 30, 2025Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  ABBOTT DIABETES CARE RECEIVED A MEDWATCH REPORT WHICH REPORTED THE FOLLOWING INFORMATION PERTAINING TO AN ABBOTT DIABETES CARE (ADC) DEVICE: THE CUSTOMER REPORTED THAT ON OCCASION, THE ADC DEVICE: "THE READER IS VERY OLD, AND IT'S VOLUME HAS SLIPPED AWAY, THEY PATIENT CAN NO LONGER HEAR ITS ALARMS." ADC CUSTOMER SERVICE ATTEMPTED TO CONTACT THE CUSTOMER 3 (THREE) TIMES TO GAIN ADDITIONAL DETAILS REGARDING THIS EVENT; FOLLOW UP ATTEMPT WAS SUCCESSFUL. THERE WAS NO REPORT OF ADVERSE EVENT OR THIRD-PARTY INTERVENTION REQUIRED DUE TO THE REPORTED PRODUCT ISSUE. 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 21937023 ↗
• MalfunctionFeb 22, 2025Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADC DEVICE IS TOO HOT TO HOLD CHARGING. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. IT IS UNKNOWN AT THIS TIME IF THE CHARGING CABLE AND ADAPTER USED WAS THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21440542 ↗
• MalfunctionFeb 21, 2025Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADC DEVICE IS TOO HOT TO HOLD WHILE CHARGING. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. IT IS UNKNOWN AT THIS TIME IF THE CHARGING CABLE AND ADAPTER USED WAS THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21440023 ↗
• MalfunctionFeb 21, 2025Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADC DEVICE IS TOO HOT TO HOLD. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. IT IS UNKNOWN IF THE CUSTOMER'S DEVICE WAS TOO HOT TO HOLD DURING USE OR WHILE CHARGING. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. IT IS UNKNOWN AT THIS TIME IF THE CHARGING CABLE AND ADAPTER USED WAS THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439683 ↗
• MalfunctionFeb 21, 2025Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADC DEVICE IS TOO HOT TO HOLD WHILE CHARGING. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. IT IS UNKNOWN AT THIS TIME IF THE CHARGING CABLE AND ADAPTER USED WAS THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439614 ↗
• MalfunctionFeb 21, 2025Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADC DEVICE IS TOO HOT TO HOLD WHILE CHARGING. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. IT IS UNKNOWN AT THIS TIME IF THE CHARGING CABLE AND ADAPTER USED WAS THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439499 ↗
• MalfunctionFeb 21, 2025Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADC DEVICE IS TOO HOT TO HOLD WHILE CHARGING. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. IT IS UNKNOWN AT THIS TIME IF THE CHARGING CABLE AND ADAPTER USED WAS THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439063 ↗
• MalfunctionFeb 21, 2025Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADC DEVICE IS TOO HOT TO HOLD WHILE CHARGING. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. IT IS UNKNOWN AT THIS TIME IF THE CHARGING CABLE AND ADAPTER USED WAS THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439045 ↗
• MalfunctionFeb 21, 2025Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADC DEVICE IS TOO HOT TO HOLD WHILE CHARGING. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. IT IS UNKNOWN AT THIS TIME IF THE CHARGING CABLE AND ADAPTER USED WAS THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21438621 ↗
• MalfunctionFeb 21, 2025Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADC DEVICE IS TOO HOT TO HOLD WHILE CHARGING. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THERE WAS NO REPORT OF FIRE, SMOKE, EXPLOSION, OR SHOCK. IT IS UNKNOWN AT THIS TIME IF THE CHARGING CABLE AND ADAPTER USED WAS THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21438181 ↗
• MalfunctionFeb 4, 2025Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ABBOTT DIABETES CARE DEVICE WAS TOO HOT TO HOLD WHILE CARRYING IT IN THEIR POCKET. CUSTOMER FURTHER REPORTS THEIR DEVICE, "CAUGHT FIRE" AND "LEFT MILD BURNS ON HIS HAND." THERE WAS NO REPORT OF SMOKE, EXPLOSION, OR SHOCK. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306745 ↗
• MalfunctionDec 19, 2024Product Quality Problem; Product Quality Problem

  THE CUSTOMER REPORTS OBSERVING VISIBLE SMOKE FROM THEIR ABBOTT DIABETES CARE DEVICE. THE CUSTOMER FURTHER DETAILS SMOKE APPEARING FROM THE READER WHEN IT WAS PUT TO CHARGE. THERE WAS NO REPORT OF FIRE, EXPLOSION, OR SHOCK. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20981675 ↗
• MalfunctionDec 2, 2024Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR CHARGING CABLE "MELTED" WHILE IT WAS PLUGGED IN. CUSTOMER FURTHER REPORTS THEY TRIED A "SECONDARY CORD" AND " IT TOO STARTED TO GET VERY HOT IMMEDIATELY." IT IS UNKNOWN AT THIS TIME IF EITHER CHARGING CABLE AND ADAPTER USED WAS THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-2023. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824334 ↗
• InjuryOct 14, 2024Failure to Power Up; Unable to Obtain Readings; Failure to Power Up; Unable to Obtain Readings

  A BATTERY/NO POWER ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER WAS UNABLE TO TEST DUE TO THE DEVICE NOT POWERING ON WITH BUTTON PRESS OR TEST STRIP INSERTION. THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL WHERE AN UNSPECIFIED CAPILLARY BLOOD GLUCOSE RESULT WAS OBTAINED. THE CUSTOMER WAS ADMINISTERED INSULIN INJECTION (DOSE/TYPE UNSPECIFIED) BY THE HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia; Loss of consciousness

  MAUDE report 20445376 ↗
• InjuryOct 9, 2024No Device Output; No Device Output

  A TESTING ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) READER. THE TEST DID NOT START AFTER THE BLOOD SAMPLE WAS APPLIED AND THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS. THERE WAS NO THIRD-PARTY TREATMENT REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 20404575 ↗
• InjurySep 19, 2024Unable to Obtain Readings; Device Displays Incorrect Message; Unable to Obtain Readings; Device Displays Incorrect Message

  A DISPLAY MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. A "CONNECTED TO PC" MESSAGE DISPLAYED WHEN THE DEVICE WAS NOT CONNECTED TO A COMPUTER, AND THE CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED SWEATING, HEART BEATING FAST AND A SEIZURE. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND RECEIVED TREATMENT OF GLUCOSE INJECTION FROM A HEALTHCARE PROFESSIONAL (HCP) DUE TO A READING THAT WENT DOWN TO THE 40'S. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Convulsion/Seizure; Diaphoresis; Hypoglycemia; Tachycardia

  MAUDE report 20260795 ↗
• MalfunctionAug 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED RECEIVING A HIGH READING FROM THEIR ABBOTT DIABETES CARE DEVICE. CUSTOMER REPORTED A HIGH READING OF 335MG/DL WHICH WAS HIGHER THAN A FREESTYLE LIBRE SCAN READING OF 165MG/DL. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063142 ↗
• MalfunctionAug 20, 2024High Readings; High Readings

  CUSTOMER REPORTS THEIR ABBOTT DIABETES CARE DEVICE, "GOT ON FIRE WHEN IT WAS CONNECTED." CUSTOMER FURTHER REPORTS "EXPLOSION" OF THEIR DEVICE HOWEVER, NO FURTHER DETAILS WERE PROVIDED. CUSTOMER REPORTS USING THE CABLE AND ADAPTER SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002214 ↗
• InjuryAug 6, 2024Failure to Power Up; Failure to Power Up

  A BATTERY/NO POWER ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) BLOOD GLUCOSE METER. THE CUSTOMER REPORTED THE METER WOULD NOT POWER ON WITH BUTTON PRESS OR TEST STRIP INSERTION. THE CUSTOMER EXPERIENCED SEIZURES AND A LOSS OF CONSCIOUSNESS. IT WAS INDICATED THAT THE CUSTOMER WAS ABLE TO SELF-TREAT WITH SUGAR PROVIDED BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 19923232 ↗
• MalfunctionJul 26, 2024Product Quality Problem; Product Quality Problem

  CUSTOMER INITIALLY REPORTED THEIR ABBOTT DIABETES DEVICE DID NOT POWER ON. THE PRODUCT WAS RETURNED AND INVESTIGATED FOR NOT BEING UNABLE TO POWER ON, HOWEVER DURING INVESTIGATION THE DEVICE BECAME TOO HOT TO HANDLE WHEN CONNECTED TO A POWER SOURCE. THIS REPORT IS BEING SUBMITTED DUE TO THE ADDITIONAL ISSUE OBSERVED DURING RETURNED PRODUCT INVESTIGATION. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840373 ↗
• MalfunctionJul 26, 2024Product Quality Problem; Product Quality Problem

  CUSTOMER INITIALLY REPORTED THEIR ABBOTT DIABETES DEVICE DID NOT POWER ON. THE PRODUCT WAS RETURNED AND INVESTIGATED FOR NOT BEING ABLE TO POWER ON, HOWEVER DURING INVESTIGATION THE DEVICE BECAME TOO HOT TO HANDLE. THIS REPORT IS BEING SUBMITTED DUE TO THE ADDITIONAL ISSUE OBSERVED DURING RETURNED PRODUCT INVESTIGATION. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT. ISSUES INVOLVING THERMAL EVENTS OCCURRING WITH ADC FREESTYLE LIBRE AND LIBRE 2 READERS IS ASSOCIATED WITH REPORT OF CORRECTIONS AND REMOVAL NUMBER 2954323-02/09/23-001-C, SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839761 ↗