BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2033030 · Received March 29, 2011

    Report

    Report Number
    2050012-2011-00905
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SUPPLEMENTAL SAMPLE INFORMATION WAS GIVEN. QC WAS WITHIN ESTABLISHED RANGES BEFORE THE EVENT AND COULD NOT CALIBRATE THE INSTRUMENT AFTER. THE BCI HOTLINE RECOMMENDED THE CUSTOMER TO PERFORM MAINTENANCE ON THE INSTRUMENT, BUT DID NOT RESOLVE THE PROBLEM. A BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND THAT THE STIRRER WAS NOT TURNING PROPERLY. THE FSE REPLACED THE STIRRER MOTOR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ONE (1) ERRONEOUSLY LOW PHOSPHORUS (PHOSM) PATIENT RESULT THAT WAS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY; HOWEVER, UPON REPEAT THE RESULT WAS MUCH HIGHER AND AN AMENDED REPORT WAS ISSUED. THE ORIGINAL FALSE RESULT WAS 0.8 MG/DL AND THE AMENDED RESULT WAS 3.4 MG/DL. PATIENT TREATMENT WAS NOT AFFECTED IN 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