BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2223789 · Received August 26, 2011

    Report

    Report Number
    2050012-2011-04886
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. PER THE CUSTOMER COMPLAINT RECORD, INTERMITTENTLY, HIGH LD QC RESULTS WERE GENERATED BY THE ANALYZER PRIOR TO AND AFTER THE EVENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND PERFORMED TROUBLESHOOTING ON THE ANALYZER. THE FSE DISCOVERED A SMALL TEAR ON THE WASH STATION MANIFOLD VALVE. THE FSE REPLACED THE VALVE, WHICH RESOLVED THE PROBLEM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER WAS INTERMITTENTLY GENERATING HIGH LACTATE DEHYDROGENASE (LD) PATIENT RESULTS DISCOVERED ON (B)(6) 2011. SOME FALSE HIGH RESULTS WERE REPORTED OUT OF THE LABORATORY. PATIENT RESULTS WERE NOT SUPPLIED BY THE CUSTOMER. THE CUSTOMER REPEATED ALL PATIENT SAMPLES RUN SINCE (B)(6) 2011. SEVERAL PATIENT SAMPLES DID NOT MATCH BECAUSE RESULTS WERE LOWER ON REPEAT. AMENDED REPORTS WERE ISSUED. THERE WAS NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1