BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1941263 · Received December 29, 2010

    Report

    Report Number
    2050012-2010-01725
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, QC RESULTS HAD BEEN ERRATIC. CUSTOMER SUPPLIED QC DATA SHOWED VALUES NEAR OR BELOW 2 SD LOW. SWITCHING TO A DIFFERENT LOT OF REAGENT RESOLVED THE ISSUE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY LOW MICRO-TOTAL PROTEIN RESULTS GENERATED BY THE UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO 007507

    Patients

    Seq Age Sex Outcome Treatment
    1