BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX 20

    MDR report key: 2083757 · Received May 10, 2011

    Report

    Report Number
    2050012-2011-01600
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CUSTOMER TECHNICAL SUPPORT ASSISTED THE CUSTOMER WITH PERFORMING A POWER DOWN/REBOOT. AFTER REBOOT, NO FURTHER INSTRUMENT ERRORS WERE OBSERVED AND PHOSM CUP DRAINED PROPERLY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE PHOSM CUP PART OF THE SYNCHRON LX20 WAS NOT DRAINING AND THAT REAGENT IS SPILLING INTO COMPARTMENT AND ONTO THE FLOOR AFTER AN UN-NOTICED SM ERROR FLAG. NO FUMES WERE PRODUCED AND CUSTOMER WAS NOT HARMED AND DID NOT NEED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX 20 CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX 20 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1