BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2469213 · Received February 27, 2012

    Report

    Report Number
    1823260-2012-01078
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    February 5, 2012
    Report Date
    February 27, 2012
    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). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 202937, EXPIRATION DATE 02/29/2012). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 1.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 26 MMOL/L ON AVIVA SYSTEM 1 AND RESULT OF 6.4 MMOL/L ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. 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 00700006574 202937

    Patients

    Seq Age Sex Outcome Treatment
    1 042 YR