BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT PLUS

    MDR report key: 1213861 · Received October 28, 2008

    Report

    Report Number
    1823260-2008-07951
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTED RECEIVING ERROR MESSAGE AND WAS UNABLE TO TEST WHILE USING THE COMPACT PLUS SYSTEM. CUSTOMER REPORTED SHE ENDED UP IN THE HOSPITAL BECAUSE SHE WAS UNABLE TO TEST. CUSTOMER REPORTS SHE WAS HOSPITALIZED DUE TO DIABETES AND WAS TREATED FOR DIABETES. CUSTOMER DID NOT RECALL HER BLOOD GLUCOSE READINGS OR THE TREATMENT SHE RECEIVED WHILE IN THE HOSPITAL. CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL INFO. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING DEVICE-NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R