BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT PLUS

    MDR report key: 1061404 · Received June 17, 2008

    Report

    Report Number
    1823260-2008-04797
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED HE HAD HYPERGLYCEMIC SYMPTOMS OF INCREASED THIRST, NAUSEA, AND VOMITING BUT WAS UNABLE TO TEST ON THE DEVICE AS IT WOULD EJECT THE STRIP BEFORE HE COULD TEST. REPORTER STATED HE CALLED THE EMTS, THEY OBTAINED A RESULT OF 594 MG/DL, TOOK HIM TO THE ER, AND HE WAS TREATED WITH A SALINE IV. REPORTER ALLEGED THE LAB TEST RESULT WAS OVER 700 MG/DL AND HE WAS ALSO TREATED WITH 10 UNITS OF NOVOLOG INSULIN THEN AND UNTIL HE WAS RELEASED 2 DAYS LATER. NO OTHER ACTIONS OR TREATMENT WERE REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R NOVOLOG - 6 YEARS| LANTUS - 3 YEARS