BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK INFORM TEST STRIPS

    MDR report key: 1080601 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05677
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT SAMPLE WAS REPORTEDLY TESTED, USING THE INFORM SYSTEM, WITH A RESULT GREATER THAN 33.3 MMOL/L. AN ADDITIONAL SAMPLE, OBTAINED FROM THE SAME PATIENT, REPORTEDLY MEASURED 8.9 MMOL/L ON A LABORATORY INSTRUMENT. REPORTER DID NOT INDICATE IF PATIENT'S THERAPY WAS MODIFIED BASED ON THE VALUE OBTAINED ON THE INFORM SYSTEM. NO ADVERSE EVENT ASSOCIATED WITH THE ALLEGED MALFUNCTION WAS REPORTED. THE MFR REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK INFORM TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS- NA NBW ROCHE DIAGNOSTICS 550084

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR ZOPICLONE 7.5 MG - ONCE DAILY| AMOXICILLIN 500/125 MG THRICE DAILY| NORTRIPTYLINE 25 MG - ONCE DAILY| VESICARE 5 MG ONCE DAILY| OXACEPAM 10MG - TWICE DAILY| METFORMIN 500 MG TWICE DAILY