BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 ANALYZER (WITHOUT CAP PIERCER)

    MDR report key: 1890407 · Received November 3, 2010

    Report

    Report Number
    2050012-2010-01190
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT REPLACEMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING THAT THE HBA1C REAGENT CARTRIDGE WAS LEAKING. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 ANALYZER (WITHOUT CAP PIERCER) CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA M003340

    Patients

    Seq Age Sex Outcome Treatment
    1