FreeStyle Libre 71525Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00357599000219), received between Oct 31, 2018 and Jul 21, 2023 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (13 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. How this data works · Data updated Oct 13, 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-1273-2023 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 17369265 ↗
• MalfunctionJul 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 17359285 ↗
• 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 17143139 ↗
• MalfunctionJun 15, 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 17135610 ↗
• MalfunctionJun 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 17129260 ↗
• 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 17117018 ↗
• 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 17017061 ↗
• MalfunctionMay 15, 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 16936541 ↗
• MalfunctionJan 10, 2023Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THEIR ADAPTER IGNITED AND THE ADAPTER AND CHARGING CABLE MELTED AND BURNED. IT IS UNKNOWN AT THIS TIME IF THE CHARGING CABLE USED WAS THE CABLE SUPPLIED BY ADC FOR USE WITH THE LIBRE DEVICE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134727 ↗
• InjuryDec 16, 2020Failure to Power Up; Failure to Power Up

  A CUSTOMER REPORTED THE ADC FREESTYLE READER DID NOT TURN ON MY BUTTON OR BY TEST STRIPS. AS A RESULT, THE CUSTOMER GLUCOSE "SKYROCKETED" WAS SENT TO THE EMERGENCY ROOM. THE CUSTOMER FURTHER REPORTED RECEIVING MEDICAL TREATMENT HOWEVER, NO TREATMENT DETAIL WAS REPORTED AS THE CUSTOMER REFUSED TO PROVIDED ADDITIONAL INFORMATION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Information

  MAUDE report 11024043 ↗
• MalfunctionSep 18, 2019Computer Operating System Problem

  RE: ABBOTT LABORATORIES FREESTYLE LIBRE: ABBOTT LAB'S PLATFORM'S CHARACTERS NUMERICAL RESTRICTION DOES NOT ALLOW FOR A FULL EXPLANATION OF ALL THE DUE DILIGENCE STEPS TAKEN BY ME TO MAKE THIS CONTRAPTION WORK; SHOULD NOT NEED A THEORETICAL MATH PH. D TO MAKE THIS WORK; I AM RECOMMENDING THAT YOUR QUALITY ASSURANCE MDS TAKE A SECOND LOOK AT THIS DEVICE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9086937 ↗
• MalfunctionMay 2, 2019Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTED WHILE USING THEIR FREESTYLE LIBRE READER THEY "NOTICED SMOKE COMING OUT OF READER AFTER CHARGING IT". CUSTOMER ALSO REPORTED THAT HE THREW THE READER OUT OF THE CAR WINDOW. 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 8574093 ↗
• InjuryApr 25, 2019Failure to Power Up; Failure to Power Up

  A CUSTOMER REPORTED THAT SHE WAS UNABLE TO TEST DUE TO HER ADC FREESTYLE LIBRE READER NOT POWERING ON WITH BUTTON PRESS OR TEST STRIP INSERTION, BECAUSE THE READER WOULDN'T CHARGE. CUSTOMER FURTHER REPORTED THAT SHE FELT ILL, SO SHE WENT TO THE EMERGENCY ROOM. THE CUSTOMER WAS ADMINISTERED INSULIN (UNSPECIFIED ROUTE) FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 8552902 ↗
• MalfunctionMar 1, 2019Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTED THAT THEIR ADC FREESTYLE LIBRE READER "SHOCKED HIM". CUSTOMER FURTHER REPORTED THAT THEIR FREESTYLE LIBRE READER CAUGHT HIS COUCH ON FIRE. HE STATED THAT " ALL OF A SUDDEN THE CABLE GOT ON FIRE AND BURNED OUT THE COUCH." 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 8382858 ↗
• MalfunctionJan 29, 2019Product Quality Problem; Product Quality Problem

  THE CUSTOMER REPORTED THAT WHILE CHARGING THEIR FREESTYLE LIBRE READER, THE USB CHARGING CABLE WAS BURNED. CUSTOMER FURTHER REPORTED IT BURNED HER USB PORT ON HER COMPUTER AND AFFECTED THE READER GIVING HER AN ERROR MESSAGE. 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 8285968 ↗
• InjuryJan 2, 2019Device Markings/Labelling Problem

  FREESTYLE LIBRE GLUCOSE MONITORING SYSTEM: THE MONITOR BOX DOES NOT CLEARLY DISTINGUISH BETWEEN A 10 DAY OR A 14 DAY READER. THE PHARMACY ATTACHED A 14 DAY READER LABEL/PRESCRIPTION LABEL TO THE BOX WHICH DOES NOT CLEARLY INDICATE WHETHER IT IS A 10 OR 14 DAY READER. SUBSEQUENTLY THE PHARMACY ISSUED A 14 DAY SENSOR, HOWEVER THE READERS DO NOT READ TEN-DAY FREESTYLE LIBRE GLUCOSE MONITORING SYSTEM: THE MONITOR BOX THAT COMES WITH THE MONITOR AND IT DOES NOT CLEARLY DISTINGUISH BETWEEN A 10 DAY AND A 14 DAY READER. THE PHARMACY ATTACHED A 14 DAY READER LABEL/PRESCRIPTION LABEL TO THE BOX WHICH DOES NOT CLEARLY INDICATE WHETHER IT IS A 10 OR 14 GAUGE READER. SUBSEQUENTLY THE PHARMACY ISSUED A 14 DAY SENSOR; HOWEVER THE MONITORS ARE NOT COMPATIBLE INVERSELY WITH 10 TO 14 DAY READERS. THE READER MUST BE COMPATIBLE WITH THE SAME SENSOR. A TEN DAY READER MUST HAVE A 10 DAY SENSOR. EVEN THOUGH THE PHARMACY PUT THE INCORRECT LABEL ON THE BOX, IF THE CONSUMER DOES NOT KNOW WHICH IS A TEN DAY BOX AND WHICH IS A 14 DAY BOX THEY CANNOT CHECK THE ACCURACY OF THE PHARMACY'S WORK. HAVING AN ELDERLY PATIENT/FAMILY MEMBER WHO IS VERY STRESSED FROM HAVING TO STICK THEIR FINGERS AND MORE PAINFUL AS TH

  Patient problems: Pain

  MAUDE report 8212758 ↗
• InjuryNov 14, 2018No Display/Image; No Display/Image

  CUSTOMER REPORTED BEING UNABLE TO TEST USING HIS FREESTYLE LIBRE READER DUE TO A BLANK SCREEN. CUSTOMER FURTHER REPORTED THAT ON AN UNSPECIFIED DATE, HE EXPERIENCED UNSPECIFIED SYMPTOMS OF HYPERGLYCEMIA AND WENT TO AN EMERGENCY ROOM, WHERE HE RECEIVED UNSPECIFIED TREATMENT FROM A HEALTHCARE PROFESSIONAL. NO FURTHER INFORMATION WAS PROVIDED AS CUSTOMER DECLINED TO CONTINUE TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 8071996 ↗
• MalfunctionOct 31, 2018Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTED THAT HE "HAD A READER WITH AN ELECTRIC SHOCK THAT RESULTED IN A FIRE. THE CUSTOMER STATES THAT HE WAS CHARGING THE READER AND THE READER BEGAN TO DEVELOP SMOKE AND THEN RESULTED IN A SMALL FIRE". 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 8024370 ↗