BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1844408 · Received September 24, 2010

    Report

    Report Number
    2050012-2010-00806
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE HEEL STICK SERUM SAMPLES FROM NEONATAL PATIENTS. PER THE CUSTOMER, BOTH SAMPLES WERE GROSSLY HEMOLYZED. HEMOLYSIS IN THE SAMPLES IS A ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW TOTAL BILIRUBIN (TBIL) RESULTS GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER FOR TWO PATIENTS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. FOR BOTH PATIENTS, MORE SAMPLES WERE DRAWN AND THE TESTS WERE REPEATED. BELIEVABLE RESULTS WERE OBTAINED AND REPORTED. THERE WAS NO EFFECT TO THE PATIENTS OR TO THE USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1