BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 2001171 · Received February 24, 2011

    Report

    Report Number
    2122870-2011-00493
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN LITHIUM HEPARIN TUBES. QC IS RUN DAILY AND HAS BEEN WITHIN THE ESTABLISHED RANGES. THE SYSTEM CHECKS WERE PERFORMED ON (B)(6) 2011, AND ALL THE RESULTS WERE WITHIN THE SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE SAMPLE WAS NOT AVAILABLE FOR REPEAT TESTING. A DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A LOWER THAN EXPECTED TOTAL BETA HCG (TBHCG) RESULT ABOVE THE NORMAL REFERENCE RANGE GENERATED BY SYNCHRON LXI 725 CLINICAL SYSTEM FOR ONE PATIENT SAMPLE. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE RESULT DID NOT CORRELATE WITH PREVIOUS AND SUBSEQUENT RESULTS. THE CUSTOMER IS NOT REPORTING PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. LXI 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR