BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO ANALYZER

    MDR report key: 1911932 · Received December 1, 2010

    Report

    Report Number
    2050012-2010-01407
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2010 AND REPLACED THE REAGENT SYRINGE DRIVE ASSEMBLY AND T-VALVE AND RAN A CARRYOVER TEST WITH NO PROBLEMS. FSE THEN RAN CONTROLS AND VERIFIED OPERATION OF THE INSTRUMENT AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A PUDDLE THAT WAS NOTICED UNDER THE REAGENT PROBE ON THE REAGENT WHEEL PROBE ACCESS DRIP TRAY. THE CUSTOMER RECEIVED REAGENT SYRINGE VERTICAL MOTION ERROR AND REPLACED THE REAGENT SYRINGE PLUNGER AND NOTICED THE PUDDLE. THE CUSTOMER ALSO NOTICED THAT THE SYRINGE DRIVE WAS MAKING A GRINDING NOISE. NO INJURY WAS REPORTED.

    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