BEUDAMED
    FDA Adverse Event Other Summary report: N

    8031673-2009-00002

    MDR report key: 1357017 · Received March 20, 2009

    Report

    Report Number
    8031673-2009-00002
    Event Type
    Other
    Date Received
    March 20, 2009
    Product Code
    JJE
    PMA / PMN Number
    K901674
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO TOSOH BIOSCIENCE, INC THAT THE CUSTOMER WAS REPORTING RESULTS WITH "NC" AND "CV" FLAGS. THE CUSTOMER REQUESTED HOW TO GET RESULTS WITH "CV" VERSUS "NC" FLAGS. "CV" IS DEFINED BY THE MFR AS "CALIBRATION VOID." "NC" IS DEFINED BY THE MFR AS "NO CALIBRATION."NEITHER SCENARIO IS ACCEPTABLE FOR REPORTING RESULTS. CUSTOMER WAS ADVISED TO RECALIBRATE TO CLEAR BOTH FLAGS AND, IF NECESSARY, RECALCULATE ANY PENDING RESULTS. CUSTOMER WAS ALSO ADVISED NOT TO REPORT ANY RESULTS WITH THESE FLAGS. PAGE 20 OF AIA 600II OPERATOR'S MANUAL IS ATTACHED FOR REVIEW. THIS PAGE CONTAINS THE FLAG DEFINITIONS AND EXPLAINS THE IMPACT TO THE RESULTS: "THE CONCENTRATION IS NOT CALCULATED USING THE CALIBRATION CURVE AND AN NC FLAG IS DISPLAYED TO INDICATE THAT THERE IS NO VALID CALIBRATION CURVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JJE

    Patients

    Seq Age Sex Outcome Treatment
    1