BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2802726 · Received October 24, 2012

    Report

    Report Number
    1823260-2012-05351
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 10, 2012
    Report Date
    December 17, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THE INITIAL REPORTER HAS REPORTED, OR INTENDS TO REPORT, THE EVENT TO FDA.

    Description of Event or Problem · 1

    PATIENT REPORTED OBTAINING BLOOD GLUCOSE RESULTS OF 130 MG/DL AND 331 MG/DL, WITHIN 1 MINUTE, ON THE AVIVA SYSTEM. PATIENT DID NOT MODIFY THERAPY BASED ON THESE RESULTS. NO ADVERSE EVENT WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    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 303523

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR LANTUS| GLIMEPIRIDE| METFORMIN