BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1082560 · Received July 23, 2008

    Report

    Report Number
    1823260-2008-05708
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 13, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN ANOTHER COUNTRY.

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT OBTAINED BACK-TO-BACK BLOOD GLUCOSE RESULTS OF 562 MG/DL AND 172 MG/DL ON THE AVIVA SYSTEM. REPORTER DID NOT INDICATE IF PT'S THERAPY WAS MODIFIED BASED ON THE VALUE OBTAINED ON THE AVIVA SYSTEM. NO ADVERSE EVENT ASSOCIATED WITH THE ALLEGED MALFUNCTION WAS REPORTED. THE SUSPECT PRODUCT WAS NOT RETURNED TO THE MFR FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK