BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1962168 · Received January 17, 2011

    Report

    Report Number
    2050012-2011-00177
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THE QC RESULTS WERE WITHIN ACCEPTABLE LIMITS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE CHEMISTRY CARTRIDGE (CC) PROBE AND WASH COLLAR AND ALSO PERFORMED THE NECESSARY ALIGNMENTS. THE FSE THEN RAN QC AND PERFORMED PRECISION STUDIES ON THE INSTRUMENT WHICH PASSED. THE CUSTOMER INDICATED THAT THE ISSUE IS RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY LOW TOTAL BILIRUBIN (TBIL) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER DID NOT KNOW HOW MANY SAMPLES WERE AFFECTED AND DID NOT HAVE ANY DATA TO SEND. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND RESULTED WITHIN NORMAL REFERENCE RANGE. SPECIFICALLY, THE CUSTOMER INDICATED THAT THE ORIGINAL RESULTS WERE 0.0 OR 0.1 MG/DL AND UPON REPEAT THE RESULTS WERE 0.5 MG/DL OR WITHIN NORMAL RANGE. NO FALSE RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO AFFECT TO PATIENT TREATMENT ASSOCIATED WITH 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1