BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT PLUS

    MDR report key: 1120776 · Received August 15, 2008

    Report

    Report Number
    1823260-2008-06271
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    July 20, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS BEING UNABLE TO TEST CUSTOMER'S BLOOD GLUCOSE ON THE COMPACT PLUS SYSTEM DUE TO AN ERROR WITHIN THE DEVICE'S SPECIFICATIONS, WHILE HE WAS HAVING LOW BLOOD GLUCOSE SYMPTOMS. CALLER POURED COKE DOWN THE CUSTOMER'S THROAT, AND HE WAS ABLE TO CONTINUE TREATMENT ON HIS OWN 15 MINUTES LATER. CUSTOMER'S SYMPTOMS IMPROVED. 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 5 YR Required Intervention HUMALOG 1:16 CARB RATIO| LANTUS 4 UNITS AM/5 UNITS PM