BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® SYSTEM

    MDR report key: 3810310 · Received May 14, 2014

    Report

    Report Number
    2050012-2014-00249
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE FOUND THE WASTE VALVE LEAKING FROM THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE. THE FSE REPLACED THE VALVE AS WELL AS THE PROBE AND WASH COLLAR. PERSONAL PROTECTIVE EQUIPMENT (PPE) NUMBER WAS NOT PROVIDED. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SUPPRESSED (NO RESULTS GENERATED) RESULTS FOR CARTRIDGE GLUCOSE (GLU) OR MAGNESIUM (MG) ON FOUR PATIENT SAMPLES INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER STATED THAT THE SAMPLES WERE REPEATED ON ANOTHER DXC ANALYZER WITH NORMAL RESULTS, WHICH WERE REPORTED. THE CUSTOMER INDICATED THAT THE QUALITY CONTROL (QC) READ IN RANGE PRIOR TO AND AFTER TESTING THE SAMPLES. THE CUSTOMER INDICATED NO ERRONEOUS RESULTS WERE GENERATED OR REPORTED ASSOCIATED WITH THIS EVENT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288878 UNICEL® DXC 800 PRO SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1