FreeStyle Libre 14 day 71936Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00357599000981), received between Sep 9, 2019 and Oct 10, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 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 17904037 ↗
• MalfunctionSep 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 17720412 ↗
• 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 17296424 ↗
• 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 17286692 ↗
• 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 17161345 ↗
• MalfunctionMay 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-23. ADC FIELD ACTION FA1005-2023 WAS ISSUED TO THE US 09FEB23.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016857 ↗
• MalfunctionMay 26, 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 17008810 ↗
• InjuryJul 29, 2022Failure to Power Up; Unable to Obtain Readings; Failure to Power Up; Unable to Obtain Readings

  A COMPLAINT WAS RECEIVED REGARDING NO POWER BY BUTTON OR BY THE TEST STRIP USING THE ADC DEVICE. AS A RESULT, THE CUSTOMER HAD A LOSS OF CONSCIOUSNESSES AND WAS PROVIDED INSULIN AND JUICE BY EMERGENCY SERVICES, AND BREAKFAST BY THE FAMILY MEMBER, FOR THE DIAGNOSIS OF HYPOGLYCEMIA. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 15129043 ↗
• MalfunctionSep 9, 2019Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTED WHILE CHARGING THEIR FREESTYLE LIBRE READER, THE "READER WAS EXTREMELY HOT AND THE DATA CABLE STARTED TO MELT AND GAVE A SMOKEY SMELL". THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8975342 ↗