BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1970688 · Received January 25, 2011

    Report

    Report Number
    1823260-2011-00415
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 234 MG/DL ON AVIVA SYSTEM 1, 109 MG/DL ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. BOTH SYSTEMS HAD PASSED VALID CONTROLS. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE 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 302753

    Patients

    Seq Age Sex Outcome Treatment
    1 079 YR CRESTOR| CANE| MULTIVITAMIN| BLOOD PRESSURE MONITOR| BLOOD PRESSURE MEDICATION| OMEGA 3 OIL| LANTUS