BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SENSOR COMFORT

    MDR report key: 1253184 · Received December 5, 2008

    Report

    Report Number
    1823260-2008-08944
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    November 17, 2008
    Report Date
    December 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN OTHER COUNTRY.

    Description of Event or Problem · 1

    CALLER REPORTS PATIENT WITH CONSISTENT BLOOD GLUCOSE RESULTS GREATER THEN 200 MG/DL OBTAINED ON THE SENSOR SYSTEM; INSULIN WAS ADMINISTERED BASED ON THE HIGH BLOOD GLUCOSE VALUES. A BLOOD GLUCOSE RESULT OF 12 MG/DL WAS OBTAINED ON A SECOND METER, WHILE A LAB VALUE OF 4MG/DL WAS OBTAINED. THE TIMEFRAME BETWEEN THE REPORTED BLOOD GLUCOSE RESULTS IS NOT KNOWN. FOLLOWING THE LAB VALUE, THE PATIENT WAS TREATED WITH GLUCOSE SOLUTION. PATIENT'S CURRENT CONDITION IS NOT KNOWN. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SENSOR COMFORT BLOOD GLUCOSE MONITORING TEST STRIPS - NA NBW ROCHE DIAGNOSTICS 450648

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention