FreeStyle Libre Pro 71562Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00357599715625), received between Mar 22, 2018 and Aug 28, 2024 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ABBOTT DIABETES CARE (ADC) RECEIVED A MEDWATCH REPORT WHICH REPORTED THE FOLLOWING INFORMATION: A CUSTOMER REPORTED AN ADHESIVE ISSUE WITH THE ADC SENSOR. THE SENSOR PREMATURELY DETACHED AND THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. THERE WAS NO THIRD PARTY TREATMENT PROVIDED FOR THE REPORTED ISSUE. 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 20086246 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER EXPERIENCED BLEEDING AFTER INSERTING THE ADC SENSOR. CUSTOMER REPORTED THEY WERE AT AN UNSPECIFIED "CLINIC" AND THE STAFF NOTICED BLEEDING COMING FROM THE ADC SENSOR SITE AND WAS ADMINISTERED UNSPECIFIED TREATMENT BY AN UNSPECIFIED THIRD-PARTY. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17209446 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROVIDER REPORTED A PATIENT EXPERIENCED A SKIN REACTION AT THE SITE OF THE ADC DEVICE, WITH SYMPTOM OF DERMATITIS. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROVIDER WHO PRESCRIBED MUPIROCIN (ANTIBIOTIC) FOR TREATMENT. IT WAS NOTED THAT THE CUSTOMER WAS ALSO USING MASTISOL (LIQUID ADHESIVE) WITH SENSOR. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Contact Dermatitis; Skin Infection

  MAUDE report 16153613 ↗
• MalfunctionMar 23, 2022Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTS THAT A PATIENT WAS BEING "ZAPPED" BY THEIR ADC DEVICE. CUSTOMER FURTHER REPORTED THAT THE PATIENT REMOVED THE ADC DEVICE AFTER FEELING THE "ELECTRIC JOLTS". THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Electric Shock

  MAUDE report 13869248 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED A CUSTOMER EXPERIENCED PAIN, REDNESS, AND SWELLING WITH WEAR OF THE FREESTYLE LIBRE PRO SENSOR. THE SENSOR WAS REMOVED AND THE HEALTHCARE PROFESSIONAL ADVISED CUSTOMER TO GO TO HOSPITAL. HOWEVER, CUSTOMER DID NOT GO TO HOSPITAL, AND WENT TO SEE ANOTHER (NON-VA) DOCTOR FOR TREATMENT. THE REPORTING HEALTHCARE PROFESSIONAL DID NOT PROVIDE DETAILS AS TO TREATMENT PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Erythema; Pain; Swelling/ Edema

  MAUDE report 13026012 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED EXPERIENCING A SKIN REACTION WHILE WEARING AN ADC FREESTYLE LIBRE PRO SENSOR AND EXPERIENCED SYMPTOMS DESCRIBED AS ITCHINESS ALL OVER HER BODY. CUSTOMER HAD CONTACT WITH DERMATOLOGIST AND RECEIVED UNSPECIFIED MEDICATION FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 12377728 ↗
• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED A SKIN REACTION AT THE SITE OF THE FREESTYLE LIBRE PRO SENSOR. THE CUSTOMER WAS EXPERIENCING PAIN WITH WEAR, AND 4 DAYS AFTER SENSOR REMOVAL, THE PATIENT DEVELOPED A RASH AT SITE OF WEAR. IT WAS INDICATED THAT THE CUSTOMER REQUIRED TREATMENT; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. ATTEMPTS TO CONTACT THE HEALTHCARE PROFESSIONAL FOR FURTHER CLARIFICATION AND INFORMATION HAVE THUS-FAR BEEN UNSUCCESSFUL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 12247037 ↗
• InjuryMay 9, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A HEALTH CARE PROFESSIONAL CONTACTED ADC TO REPORT THAT A TIP OF THE SENSOR FILAMENT WAS LEFT IN THE CUSTOMER¿S ARM ON (B)(6) 2019. IT WAS FURTHER REPORTED THAT CUSTOMER REQUIRED MEDICAL ATTENTION FOR THE REMOVAL OF THE SENSOR TIP FROM THE CUSTOMER'S ARM. THE HCP USED STERILE SUTURE REMOVING TWEEZERS TO EXTRACT THE FILAMENT FROM A CUSTOMER¿S ARM. NO FURTHER TREATMENT OR MEDICATION WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Information

  MAUDE report 8597334 ↗
• InjuryMay 9, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AN HCP REPORTED A CUSTOMER EXPERIENCED AN ALLERGIC SKIN REACTION ON DAY 3 OF WEAR OF THE ADC FREESTYLE LIBRE PRO SENSOR. THE CUSTOMER PRESENTED WITH "REDNESS AND BUMPS" JUST ON HER RIGHT ARM AND SELF-TREATED WITH BENADRYL, CLARITIN AND HYDROCORTISONE CREAM. A COUPLE OF DAYS LATER, THE REDNESS AND BUMPS FROM THE RIGHT UPPER ARM HAD SPREAD AND "WEEPING YELLOWISH" DISCHARGE WAS NOTED. THE CUSTOMER HAD HCP CONTACT AND WAS ADMINISTERED AN INJECTION OF THE STEROID, KENALOG (DOSE UNKNOWN,) AND WAS GIVEN A PRESCRIPTION FOR AUGMENTIN (AMOXICILLIN, DOSE UNKNOWN) FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Erythema; Purulent Discharge; Skin Irritation; Swelling; Unspecified Infection

  MAUDE report 8596675 ↗
• InjuryApr 12, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A HEALTH CARE PROFESSIONAL CONTACTED ADC TO REPORT THAT A TIP OF THE SENSOR FILAMENT WAS LEFT IN THE CUSTOMER¿S ARM ON (B)(6) 2019. IT WAS FURTHER REPORTED THAT CUSTOMER REQUIRED MEDICAL ATTENTION FOR THE REMOVAL OF THE SENSOR TIP FROM THE CUSTOMER'S ARM. THE HCP USED STERILE SUTURE REMOVING TWEEZERS TO EXTRACT THE FILAMENT FROM A CUSTOMER¿S ARM. NO FURTHER TREATMENT OR MEDICATION WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Information

  MAUDE report 8511669 ↗
• InjuryMar 21, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AN HCP REPORTED A CUSTOMER EXPERIENCED AN ALLERGIC SKIN REACTION ON DAY 3 OF WEAR OF THE ADC FREESTYLE LIBRE PRO SENSOR. THE CUSTOMER PRESENTED WITH "REDNESS AND BUMPS" JUST ON HER RIGHT ARM AND SELF-TREATED WITH BENADRYL, CLARITIN AND HYDROCORTISONE CREAM. A COUPLE OF DAYS LATER, THE REDNESS AND BUMPS FROM THE RIGHT UPPER ARM HAD SPREAD AND "WEEPING YELLOWISH" DISCHARGE WAS NOTED. THE CUSTOMER HAD HCP CONTACT AND WAS ADMINISTERED AN INJECTION OF THE STEROID, KENALOG (DOSE UNKNOWN,) AND WAS GIVEN A PRESCRIPTION FOR AUGMENTIN (AMOXICILLIN, DOSE UNKNOWN) FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Erythema; Purulent Discharge; Skin Irritation; Swelling; Unspecified Infection

  MAUDE report 8440373 ↗
• InjuryMar 22, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NURSE AND AN ADC SALES REPRESENTATIVE REPORTED THAT ON (B)(6) 2018 WHILE THE HEALTH CARE PROVIDER (HCP) WAS GOING THROUGH THE NORMAL INSERTION PROCESS WITH A PATIENT THE ADC FREESTYLE LIBRE SENSOR FAILED TO ACTIVATE SO THE HCP REMOVED THE SENSOR. UPON REMOVAL OF THE SENSOR IT WAS DISCOVERED THAT THE SHARP HAD REMAINED IN THE PATIENT¿S ARM. THE HCP REMOVED THE SHARP FROM THE PATIENT¿S ARM, TREATED THE AREA PROPHYLACTICALLY WITH AN UNSPECIFIED ¿ANTIBIOTIC OINTMENT¿ AND BANDAGED THE WOUND. THE PATIENT WAS ALSO ADVISED TO TAKE IBUPROFEN FOR ANY PAIN AND/OR SWELLING. NO ADDITIONAL TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Information

  MAUDE report 7363640 ↗