BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1781441 · Received August 3, 2010

    Report

    Report Number
    1823260-2010-04574
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 215 MG/DL AND 114 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Description of Event or Problem · 1

    THE CUSTOMER PERFORMED CONTROL TESTS ON HIS BREEZE2 AND RECEIVED A RESULT OF 280 MG/DL. THE NORMAL CONTROL RANGE WAS 119-172 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.

    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 302629

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR CRESTOR| FORTAMET| AZOR| LEVOTHYROXINE