BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I ACCESS IMMUNOANALYZER

    MDR report key: 2298962 · Received October 17, 2011

    Report

    Report Number
    2122870-2011-01126
    Event Type
    Malfunction
    Date Received
    October 17, 2011
    Date of Event
    September 15, 2011
    Report Date
    September 15, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED "NO VALUE IND" FLAGGED ACCUTNI RESULTS FOR TWO PATIENTS. ACCUTNI REAGENT A78803 L/N 110410 AND ACCESS ACCUTNI CALS S0 TO S5 L/N 023153 EXHIBITED THE PROBLEM. THROUGH TROUBLESHOOTING, IT WAS DETERMINED THAT THE S0 CALIBRATOR RLUS WERE ELEVATED AS COMPARED TO IN-HOUSE QC RELEASE DATA. CUSTOMER TECHNICAL SUPPORT (CTS) INSTRUCTED THE CUSTOMER TO RECALIBRATE. RECALIBRATION RESOLVED THE ISSUE. FOR SANDWICH ASSAYS, SUCH AS ACCUTNI, THIS CAN CAUSE A SHIFT DOWN IN BOTH QC AND PATIENTS' SAMPLES. THEREFORE, THE POTENTIAL FOR REPORTING ERRONEOUS BUT BELIEVABLE RESULTS DOES EXIST. NO ROOT CAUSE WAS DETERMINED FOR THE ELEVATED S0 RLUS. THE CUSTOMER DID NOT REPORT DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I ACCESS IMMUNOANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. DXC 600I

    Patients

    Seq Age Sex Outcome Treatment
    1