BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1836020 · Received September 15, 2010

    Report

    Report Number
    2050012-2010-00778
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    December 16, 2009
    Report Date
    September 15, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS NOT PROVIDED BY THE CUSTOMER. THE LAB SUSPECTS THE INITIAL RESULTS SUPPRESSED "OIR LOW" MAY HAVE BEEN CAUSED BY A BUBBLE IN THE SAMPLE. THIS INCIDENT WAS A SAMPLE SPECIFIC EVENT, SERVICE IS NOT APPLICABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ONE VALPROIC ACID (VPA) SAMPLE THAT WAS SUPPRESSED WITH AN "OIR LOW" (OUT OF INSTRUMENT RANGE LOW) FLAG THAT WAS GENERATED BY THE UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER. THE OPERATOR PERFORMED DILUTIONS WITH SALINE AND FOUND THAT THE RESULTS FROM THE VARIOUS DILUTIONS DID NOT MATCH. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1