BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO ANALYZER

    MDR report key: 2061677 · Received April 18, 2011

    Report

    Report Number
    2050012-2011-01216
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY ERRATIC GLUCM PATIENT RESULTS NOTICED WHEN RUNNING IN DUPLICATE MODE. THERE WAS NO AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1