BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUCOMETER DEX

    MDR report key: 389396 · Received April 11, 2002

    Report

    Report Number
    1810909-2002-00026
    Event Type
    Other
    Date Received
    April 11, 2002
    Date of Event
    March 16, 2002
    Report Date
    April 10, 2002
    Manufacturer
    BAYER DIAGNOSTICS
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED THAT INDICATED THE CLUCOMETER DEX SYSTEM GAVE A READING OF 128 MG/DL. HOWEVER, THE CUSTOMER WAS NOT FEELING WELL AND "ACTED DRUNK". EMT'S PERFORMED A BLOOD GLUCOSE MEASUREMENT (METHOD UNKNOWN) WITHIN FIVE MINUTES OF THE 128 MG/DL READING AND RECEIVED A RESULT OF 32 MG/DL. WHILE ON THE PHONE ELECTRONIC CHECKS WERE CONDUCTED AND WERE SATISFACTORY. HOWEVER, THE CUSTOMER WAS NOT FEELING WELL TO CONTINUE WITH THE EVALUATION OF THE REAGENT. THE CUSTOMER WILL BE SUPPLIED A CONTROL SOLUTION TO CONTINUE WITH THE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER DEX BLOOD GLUCOSE METER CFR BAYER DIAGNOSTICS 3952E *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other