BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 12812949 · Received November 12, 2021

    Report

    Report Number
    MW5105286
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    November 7, 2021
    Report Date
    November 9, 2021
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    PJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPORTED AS DANGEROUSLY LOW; I PUT THE SENSOR ON (B)(6) 2021 IT WORKED FINE UNTIL THE EVENING OF (B)(6). THE MONITOR TOLD ME MY SUGAR LEVEL WAS BELOW 80. I DIDN'T FEEL HYPOGLYCEMIC BUT THIS ALARMED ME SO I ATE SOME THINGS WITH SUGAR IN IT TO RAISE IT UP I KEPT CHECKING MY SUGAR ALL NIGHT AND IT STARTED TELLING ME IT WAS "LOW" OR UNDER 40. I DID NOT HAVE ANOTHER METER TO CHECK IT WITH. I WORK AT A MEDICAL FACILITY AND CHECKED MY SUGAR THERE AND IT WAS 140. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700151 FREESTYLE LIBRELINK CONTINUOUS GLUCOSE MONITOR SECONDARY DISPLAY PJT ABBOTT DIABETES CARE INC. 210726P

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other BIOTIN | GLYXAMBI| HUMALOG | HUMIRA| LAMFUN| MULTIVITAMIN | REQUIP BYDUREON| TIROSINT| ZOLOFT