BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 16966896 · Received May 19, 2023

    Report

    Report Number
    2954323-2023-20434
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    April 3, 2023
    Report Date
    May 19, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT, AND IT HAS BEEN DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DHRS (DEVICE HISTORY RECORD) FOR THE LIBRE SENSOR AND SENSOR KIT WERE REVIEWED, AND THE DHRS SHOWED THE LIBRE SENSOR AND SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER AND THEIR CAREGIVER (WHO IS A HEALTHCARE PROFESSIONAL) REPORTED AN ISSUE WITH THE ADC (ABBOTT DIABETES CARE) DEVICE, IN WHICH THEY REPORTED LOWER SENSOR READINGS WITH THE SENSOR, AS COMPARED TO A COMPETITOR CAPILLARY METER. IT WAS REPORTED THAT IN JANUARY, THE CUSTOMER HAD DEVELOPED DIABETIC FOOT WITH LIMB ISCHEMIA. SINCE THIS TIME, THE CUSTOMER HAD REPEATED ADMISSIONS INTO HOSPITAL FOR THIS HEALTH ISSUE. UPON THE LATEST ADMISSION, ON (B)(6) 2023, THE CUSTOMER HAD ALL TOES ON THEIR LEFT FOOT AMPUTATED ON (B)(6) 2023. THE CUSTOMER WAS ADDITIONALLY TREATED WITH FIASP INSULIN (DOSE UNKNOWN), TRESIBA (DOSE UNKNOWN), GLYCIPHAGE TABLETS, TRAJENTA 5 MG 1/DAY, AND METFORMIN 500 MG FOR MANAGEMENT OF DIABETES. THE CUSTOMER WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2023. THE CUSTOMER DID NOT PROVIDE ANY SENSOR READINGS OR CAPILLARY RESULTS FROM PRIOR TO AMPUTATION. HOWEVER, THE FOLLOWING READINGS COMPARISONS WERE PROVIDED: 118 MG/DL FROM SENSOR AGAINST 170 MG/DL FROM CAPILLARY METER (TAKEN 13 APR 2023), 185 MG/DL FROM SENSOR AGAINST 273 MG/DL FROM CAPILLARY METER (TAKEN 15 APR 2023), AND 222 MG/DL FROM SENSOR AGAINST 173 MG/DL FROM CAPILLARY METER (TAKEN 16 APR 2023). THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FALL INTO THE "B" ZONE. PER THE READINGS COMPARISONS THAT WERE PROVIDED BY THE CUSTOMER, THERE WAS NO INDICATION THAT CUSTOMER HAD A CLINICALLY SIGNIFICANT DIFFERENCE IN READINGS FROM THE SENSOR. THE REPORTED ADVERSE HEALTH EFFECT OF PVD (PERIPHERAL VASCULAR DISEASE), WHICH CAN LEAD TO AMPUTATION, IN RELATION TO DIABETIC COMPLICATIONS IS A KNOWN CONSEQUENCE OF PROLONGED MISMANAGEMENT OF DIABETES OVER SEVERAL YEARS, AND WOULD BE UNLIKELY TO BE CAUSED BY USE OF THE SENSOR (CGM). ADDITIONALLY, IT SHOULD BE ASSUMED THAT OVER THE COURSE OF THE CUSTOMER'S REPEATED ADMISSIONS TO HOSPITAL PRIOR TO THE REQUIRED AMPUTATION, THAT THE CUSTOMER'S DIABETIC THERAPY WOULD HAVE BEEN ADJUSTED BY THEIR HEALTHCARE PROVIDER, PER DIABETES MANAGEMENT STANDARDS. IT WAS STATED THAT THE CUSTOMER AND CAREGIVER DID NOT WANT ADC TO MAKE FURTHER CONTACT REGARDING THIS ISSUE, AND THAT THEY DID NOT HAVE FURTHER INFORMATION TO PROVIDE. THEREFORE, NO FURTHER INFORMATION CAN BE PROVIDED BY ADC AT THIS TIME. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT, AND ABBOTT DIABETES CARE (ADC) DOES NOT CONSIDER THE ADC DEVICE TO HAVE CAUSED OR CONTRIBUTED TO THE REPORTED IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623646 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H