BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS

    MDR report key: 1896292 · Received November 10, 2010

    Report

    Report Number
    2050012-2010-01221
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 19, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS RUN BEFORE AND AFTER THE EVENT AND WAS WITHIN THE ESTABLISHED RANGES. BCI CTS (CUSTOMER TECHNICAL SUPPORT) PERFORMED TROUBLESHOOTING WITH THE CUSTOMER: CRE MODULE MAINTENANCE, LAMP CALIBRATION AND CHEMISTRY CALIBRATION, PRECISION RUNS FOR BOTH LOW AND HIGH LEVELS OF SERUM AND URINE QC AND THE RESULTS WERE ACCEPTABLE. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE AND OBSERVED THAT THE INSTRUMENT HAD THE ORIGINAL CRE MODULE WITH THE OLDER STYLE STIRRER MOTOR AND ORDERED THE NEW STYLE BRUSH STIRRER MOTOR FOR REPLACEMENT. THE FOLLOWING MED-WATCH REPORTS ARE LINKED TO THIS EVENT: 2050012-2010-01220, 2050012-2010-00893.

    Additional Manufacturer Narrative · 1

    QC WAS RUN BEFORE AND AFTER THE EVENT AND WAS WITHIN THE ESTABLISHED RANGES. BCI CTS (CUSTOMER TECHNICAL SUPPORT) PERFORMED TROUBLESHOOTING WITH THE CUSTOMER: CRE MODULE MAINTENANCE, LAMP CALIBRATION AND CHEMISTRY CALIBRATION, PRECISION RUNS FOR BOTH LOW AND HIGH LEVELS OF SERUM AND URINE QC AND THE RESULTS WERE ACCEPTABLE. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE AND OBSERVED THAT THE INSTRUMENT HAD THE ORIGINAL CRE MODULE WITH THE OLDER STYLE STIRRER MOTOR AND ORDERED THE NEW STYLE BRUSH STIRRER MOTOR FOR REPLACEMENT. THE FOLLOWING MED-WATCH REPORTS ARE LINKED TO THIS EVENT: 2050012-2010-01220, 2050012-2010-00893. CHANGE: FROM: NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT. TO: UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO TWO FALSE LOW CREATININE (CRE) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. UPON REPEAT, THE INSTRUMENT YIELDED HIGHER RESULTS. UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO TWO FALSE LOW CREATININE (CRE) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. UPON REPEAT, THE INSTRUMENT YIELDED HIGHER RESULTS. NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1