BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1934700 · Received December 21, 2010

    Report

    Report Number
    1823260-2010-07599
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 15, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 1 MINUTE: 247 MG/DL AND 81 MG/DL. CUSTOMER OBTAINED READING OF 247 MG/DL WITH AVIVA STRIP LOT 302801. CUSTOMER OBTAINED READING OF 81 MG/DL WITH AVIVA STRIP LOT 303016. METER WAS CODED CORRECTLY WITH EACH LOT OF STRIPS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS 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 303016

    Patients

    Seq Age Sex Outcome Treatment
    1