BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE II TEST STRIPS

    MDR report key: 1780643 · Received September 27, 2007

    Report

    Report Number
    1823260-2007-08439
    Event Type
    Malfunction
    Date Received
    September 27, 2007
    Date of Event
    August 29, 2007
    Report Date
    September 27, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT PT'S BLOOD GLUCOSE WAS MEASURED ON THE ADVANTAGE SYSTEM WITH A RESULT OF 28.3 MMOL/L. AN ADDITIONAL SAMPLE OBTAINED FROM THE SAME PT WAS REPORTEDLY TESTED ON A LABORATORY INSTRUMENT WITH A RESULT OF 4.7 MMOL/L. THE TIME BETWEEN SAMPLE COLLECTIONS WAS NOT PROVIDED. NO TREATMENT, BASED ON THE VALUE OBTAINED ON THE ADVANTAGE SYSTEM, WAS REPORTED. THE MFR REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 449523

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK