BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CHEMISTRY ANALYZER

    MDR report key: 2032995 · Received March 29, 2011

    Report

    Report Number
    2050012-2011-00906
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 19, 2011
    Report Date
    February 28, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THE SAMPLE WAS NORMAL IN APPEARANCE. QC WAS WITHIN ESTABLISHED RANGES BEFORE AND AFTER THE EVENT. THE INSTRUMENT WAS ALSO GIVING NO OR LOW REAGENT IN THE TPM CUP ERRORS. A BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE VALVE BANK ON THE TPM CUP MODULE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ONE (1) ERRONEOUSLY LOW TOTAL PROTEIN (TPM) PATIENT RESULT THAT WAS GENERATED BY THE SYNCHRON LX20 PRO CHEMISTRY ANALYZER. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY; HOWEVER, UPON REPEAT THE RESULT WAS MUCH HIGHER AND AN AMENDED REPORT WAS ISSUED. THE ORIGINAL FALSE RESULT WAS 2.0 MG/DL AND THE AMENDED RESULT WAS 7.7 MG/DL. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1