BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2180031 · Received July 27, 2011

    Report

    Report Number
    1823260-2011-04030
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 21, 2011
    Report Date
    September 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). MEDWATCH WITH IDENTIFIER (B)(6) IS FOR CUSTOMER MOBILE SYSTEM, MEDWATCH WITH IDENTIFIER (B)(6) IS FOR CUSTOMER AVIVA SYSTEM.

    Description of Event or Problem · 1

    CALLER REPORTED MOBILE SYSTEM BLOOD GLUCOSE RESULT OF 28.3 MMOL/L AND AVIVA SYSTEM RESULT OF 8.3 MMOL/L WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. 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 203044

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR