BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2222093 · Received August 24, 2011

    Report

    Report Number
    1823260-2011-04545
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 4, 2011
    Report Date
    September 1, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH (B)(6) IS FOR AVIVA SYSTEM 1, MEDWATCH WITH (B)(6) IS FOR AVIVA SYSTEM 2.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 76 MG/DL AND 66 MG/DL ON AVIVA SYSTEM 1, 157 MG/DL, 60 MG/DL, 123 MG/DL, 76 MG/DL, AND 93 MG/DL ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT 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 303294

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR GLYBURIDE| METFORMIN