FreeStyle Libre 14 day 71937Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00357599000974), received between Apr 18, 2019 and Feb 21, 2025 — classified as 33 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (45 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 82 reports, in the reporter's own words as published by the FDA.

• 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 21440291 ↗
• InjurySep 6, 2024Failure to Power Up; Failure to Power Up

  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 WEAKNESS, "COULD NOT STAND AND KEPT SITTING DOWN", AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS ADMITTED IN THE HOSPITAL AND RECEIVED UNSPECIFIED TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Fatigue; Hyperglycemia

  MAUDE report 20163918 ↗
• MalfunctionApr 18, 2024Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ABBOTT DIABETES 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 ABBOTT DIABETES CARE 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 19139793 ↗
• MalfunctionOct 12, 2023Product 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 17917737 ↗
• MalfunctionSep 29, 2023Product 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-2023. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842788 ↗
• MalfunctionSep 20, 2023Product 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 17779474 ↗
• MalfunctionSep 14, 2023Product 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 17743088 ↗
• MalfunctionAug 31, 2023Product 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 17663481 ↗
• InjuryAug 16, 2023Unable to Obtain Readings; Unable to Obtain Readings

  A UNSPECIFIED ISSUE WAS REPORTED WITH THE ADC DEVICE. CUSTOMER WAS UNABLE TO OBTAIN READINGS DUE TO THE DEVICE "WAS LOST DUE TO A CAR ACCIDENT". THE CUSTOMER REPORTED UNSPECIFIED TREATMENT FROM THIRD-PARTY DUE TO THIS ISSUE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 17555767 ↗
• MalfunctionAug 7, 2023Product 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 17468372 ↗
• MalfunctionAug 1, 2023Product 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 17432279 ↗
• MalfunctionJul 31, 2023Product 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 17423040 ↗
• MalfunctionJul 21, 2023Product 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 17369001 ↗
• MalfunctionJul 11, 2023Product 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 17299018 ↗
• MalfunctionJul 10, 2023Product 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 17285689 ↗
• MalfunctionJul 7, 2023Product 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 17276599 ↗
• MalfunctionJul 5, 2023Product 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 17259425 ↗
• MalfunctionJul 5, 2023Product 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 17254885 ↗
• MalfunctionJul 3, 2023Product 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 17246150 ↗
• MalfunctionJun 30, 2023Product 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 (B)(4). SUBMITTED TO THE FDA ON 09-FEB-23. ADC FIELD ACTION (B)(4). WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17235992 ↗
• MalfunctionJun 20, 2023Product 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 17162795 ↗
• MalfunctionJun 16, 2023Product 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 17143281 ↗
• MalfunctionJun 13, 2023Product 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 17116439 ↗
• MalfunctionJun 13, 2023Product 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 17115930 ↗
• MalfunctionMay 30, 2023Product 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 17019062 ↗