BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1933432 · Received December 20, 2010

    Report

    Report Number
    1823260-2010-07558
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 12, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CALLER REPORTEDLY USED TWO DIFFERENT TEST STRIP VIALS TO OBTAIN THE REPORTED VALUES, BUT DID NOT KNOW WHICH VIAL PRODUCED WHICH ERRONEOUS RESULT. (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 160 MG/DL, 325 MG/DL, AND 156 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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 ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 302759

    Patients

    Seq Age Sex Outcome Treatment
    1 METFORMIN TWICE DAILY| PRANDIN