BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 6494955 · Received April 14, 2017

    Report

    Report Number
    3011393376-2017-02173
    Event Type
    Malfunction
    Date Received
    April 14, 2017
    Date of Event
    March 25, 2017
    Report Date
    July 11, 2017
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: ON (B)(6) 2017, 66 MG/DL, 135 MG/DL, 150 MG/DL AND 60 MG/DL. ON (B)(6) 2017, 80 MG/DL AND 210 MG/DL. ON (B)(6) 2017, 65 MG/DL AND 189 MG/DL. NO ADVERSE EVENT REPORTED. RETURN OF THE SUSPECT DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276180 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 496387

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR