BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO ANALYZER

    MDR report key: 2241822 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05096
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND REPLACED THE CREATININE MODULE REAGENT SYRINGE AFTER NOTING THAT IT WAS LEAKING. CALIBRATION AND QC TESTING WAS PERFORMED WITH NO PROBLEMS. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT A CREATININE (CRE) MODULE IN THE SYNCHRON LX20 PRO ANALYZER HAD LEAKED AND CRE REAGENT WAS LEAKING ONTO THE FLOOR. NO INJURY OR EXPOSURE WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1