BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT

    MDR report key: 1133189 · Received August 22, 2008

    Report

    Report Number
    1823260-2008-06385
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED HE ATTEMPTED TO OBTAIN HIS BLOOD GLUCOSE LEVELS ON HIS COMPACT SYSTEM WHEN HE BEGAN FEELING DIZZY AND LIGHTHEADED, BUT COULDN'T BECAUSE IT DIDN'T HAVE ANY POWER. REPORTER STATED THAT HE CALLED HIS DR AND WENT IN TO THE OFFICE. REPORTER STATED THAT HIS DR FOUND GLUCOSE IN HIS URINE, OBTAINED A RESULT OF 290 MG/DL, AND TREATED HIM WITH AN INSULIN INJECTION. REPORTER STATED THE DR ALSO DOUBLED HIS GLYBURIDE MEDICATION TO 5 MG TWICE DAILY. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT REC'D. 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 BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention GLYBURIDE - 4-5 YEARS - 2.MG TWICE DAILY