BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE

    MDR report key: 1338598 · Received March 11, 2009

    Report

    Report Number
    1823260-2007-05142
    Event Type
    Malfunction
    Date Received
    March 11, 2009
    Date of Event
    March 16, 2007
    Report Date
    June 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K021827
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: NOVOLOG 201-250 = 3UNITS; NOVOLOG 301-350 = 7UNITS; NOVOLOG >401 = 11UNITS; NOVOLOG 151-200 =2UNITS; NOVOLOG 251-300 =5UNITS; NOVOLOG 351-400 =9UNITS.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 200 MG/DL AND 80 MGDL WITHIN 10 MINUTES ON THE ACTIVE SYSTEM. LOW BLOOD GLUCOSE SYMPTOMS REPORTED WITH THESE RESULTS; SELF TREATED WITH JUICE. NO QUALITY CONTROLS WERE USED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIAGNOSTICS 22954535

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR GLUCOPHAGE 500MG TWICE DAILY| LANTUS 35UNITS EVENING| NOVOLOG 101-150 = UNIT