BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE SENSOR KIT AND READER 14 DAY

    MDR report key: 9720617 · Received February 14, 2020

    Report

    Report Number
    MW5093019
    Event Type
    Injury
    Date Received
    February 14, 2020
    Date of Event
    February 11, 2020
    Report Date
    February 12, 2020
    Manufacturer
    ABBOTT DIABETES CARE, INC.
    Product Code
    MDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AS USER OF FREESTYLE LIBRE 14 DAY CGM FOR 1+ YEARS, RECENTLY SINCE (B)(6) 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 IN FASTING SUGAR AS MEASURED IN A SUTTER HEALTH, PALO ALTO LAB SERUM WAS 121 MG/DL WHILE FREESTYLE LIBRE GAVE 94 READING AS MEASURED SEVERAL TIMES WITHIN 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. I HAVE EXPERIENCED SIMILARLY OFF READINGS REPEATEDLY BEEN ON CALL ON NEARLY EVERY 14 DAYS SENSOR 2 IN DECEMBER, 2 IN JANUARY AND OW, THIS IS THE LATEST REPLACEMENT ONE SENT BY THEM APPLIED (B)(6) 2020. IT SEEMS COMPANY IS SHIPPING SENSORS THAT ARE NOT CALIBRATED OR OUT OF WHACK. THE ABOVE IS THE REF TEST RANGE. FREESTYLE LIBRE 14 DAY GAVE 94 READING WITHIN 1 AND 5 MINS OF BLOOD DRAW. MULTIPLE LOTS (B)(6) 2019 - (B)(6) 2020. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177991 FREESTYLE LIBRE SENSOR KIT AND READER 14 DAY SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE, INC.
    177992 FREESTYLE LIBRE SENSOR KIT AND READER 14 DAY SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE, INC.
    177993 FREESTYLE LIBRE SENSOR KIT AND READER 14 DAY SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE, INC.
    177994 FREESTYLE LIBRE SENSOR KIT AND READER 14 DAY SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE, INC.
    177995 FREESTYLE LIBRE SENSOR KIT AND READER 14 DAY SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other