BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 6289362 · Received January 31, 2017

    Report

    Report Number
    3011393376-2017-00663
    Event Type
    Malfunction
    Date Received
    January 31, 2017
    Date of Event
    January 15, 2017
    Report Date
    March 3, 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
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. REFERENCE THE FOLLOWING MEDWATCHES WITH A1 PATIENT IDENTIFIERS FOR THE FOLLOWING SYSTEMS: CN-200428 - CPLA-0002244466 ¿ AVIVA METER - SYSTEM 1 - SERIAL NUMBER - (B)(4). CN-200429 - CPLA-0002244551 ¿ AVIVA METER - SYSTEM 2 - SERIAL NUMBER ¿ (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS WITHIN 10 MINUTES: 252 MG/DL ON AVIVA SYSTEM (SYSTEM 1) AND 121 MG/DL ON HUSBAND¿S AVIVA SYSTEM (SYSTEM 2). THE SAME LOT BUT DIFFERENT VIALS WERE USED ON BOTH METERS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED DEVICE FOR EVALUATION AND REPLACEMENT WAS SENT. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71929 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 496062

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR