BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE

    MDR report key: 185626 · Received August 20, 1998

    Report

    Report Number
    1810909-1998-00005
    Event Type
    Malfunction
    Date Received
    August 20, 1998
    Date of Event
    January 17, 1998
    Report Date
    August 20, 1998
    Manufacturer
    KDK CORP.
    Product Code
    CGA
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT HER GLUCOMETER ELITE IS READING TOO LOW. DURING RECENT EVALUATION HER BLOOD SUGAR RESULTS WERE IN THE 30-40 MG/DL RANGE. CUSTOMER CHECKED METER WITH CONTROL SOLUTION WHICH LIKEWISE GAVE A LOW RESULT. CHECK STRIP GAVE SATISFACTORY RESULTS. TECHNIQUE WAS REVIEWED AND FOUND SATISFACTORY. THE METER WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE BLOOD GLUCOSE METER CGA KDK CORP. 3901A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN