BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 7627371 · Received June 21, 2018

    Report

    Report Number
    2531491-2018-00001
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    May 12, 2018
    Report Date
    May 22, 2018
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    NBW
    UDI-DI
    00682607557158
    PMA / PMN Number
    K132086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS METER IS READING LOW. HE HAD BEEN TESTING AND GETTING NORMAL BLOOD SUGARS BUT ON SATURDAY ((B)(6) 2018) HE WAS SYMPTOMATIC OF HIGH BLOOD SUGARS (SWEATING, FELT SHAKY) SO HE WENT TO THE HOSPITAL. AT THE HOSPITAL HIS BLOOD SUGAR WAS OVER 500 MG/DL. THEY TREATED HIM FOR HIGH BG AND HE WAS RELEASED ON THURSDAY. HE BOUGHT A CONTOUR NEXT METER AND HE TESTED HIS OCX METER AGAINST THE CONTOUR (OCX=24 MG/DL AND THE CONTOUR=165 MG/DL). HE TRIED TESTING THE OCX CONTROL BUT HE COULD NOT GET A READING. HIS STRIPS HAVE BEEN OPEN 1 DAY. CUSTOMER WAS HOSPITALIZED ON SATURDAY, TREATED FOR HIGH BLOOD SUGAR, AND RELEASED ON THURSDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470222 ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM BLOOD GLUCOSE MONITORING SYSTEM NBW ACON LABORATORIES, INC. G115-10D 00682607557158

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization