BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 12776076 · Received November 8, 2021

    Report

    Report Number
    2954323-2021-91560
    Event Type
    Injury
    Date Received
    November 8, 2021
    Date of Event
    February 12, 2021
    Report Date
    November 8, 2021
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS AN INITIAL FINAL REPORT. THIS ISSUE DOES NOT MEET REPORTABILITY CRITERIA, HOWEVER IT IS BEING REPORTED TO FDA AS THE COMPLAINT WAS RECEIVED VIA USER REPORT. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED AFTER ALL INVESTIGATION ACTIVITIES ARE COMPLETE. CUSTOMER REPORTED 2 SENSORS (SERIAL NUMBERS UNKNOWN), BOTH SENSOR ISSUES HAVE BEEN CAPTURED UNDER THIS SUBMISSION. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    ABBOTT DIABETES CARE RECEIVED A MEDWATCH REPORT IN WHICH THE CUSTOMER REPORTED TWO ADC FREESTYLE LIBRE SENSORS PROVIDED LOW READINGS WHEN COMPARED TO LABORATORY AND CAPILLARY TEST RESULTS. DETAILS OF THE USER REPORT ARE AS FOLLOWS: "RECENTLY SINCE 2019 NOTICING 20-35 MG/DL ERROR IN COMPARISON TO REF LAB AND TEST STRIPS, THIS HAS BEEN NOTICED WITH LATEST REPLACEMENT SENSORS SENT BY COMPANY BY FEDEX AND DESPITE TROUBLE SHOOTING WITH THEIR TECHNICAL SUPPORT STAFF - ALL GUIDELINES WERE MET, IN PAST ERROR 1 YEAR AGO HAD BEEN LESS +/- 10 MG/DL. YESTERDAY (B)(6) 2020 INU FASTING SUGAR AS MEASURED IN A SUTTER HEALTH, PALO ALTO LAB SERUM WAS 121 MG/DL WHILE FREESTYLE LIBRE GAVE 94 READINGS AS MEASURED SEVERAL TIMES WIHIN 1 - 5 MINS OF BLOOD DRAW. ONE TOUCH ULTRA TEST STRIPS IN CONTRAST WAS 123 WELL IN TIGHT RANGE. THIS IS UNACCEPTABLE ABOUT 23 % OFF". THERE WAS NO REPORT OF SELF-TREATMENT OR THIRD-PARTY MEDICAL INTERVENTION. BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT OF SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672262 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Male