BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX®20 PRO CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2251915 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-04075
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE REPLACED THE SAMPLE SYRINGE AND THE REAGENT SYRINGE. THE FSE VERIFIED THE REPAIRS BY PERFORMING A PRECISION ANALYSIS AND BY ASSAYING QUALITY CONTROLS. THE EVENT DESCRIBED IN THIS MEDWATCH REPORT IS SIMILAR TO ANOTHER EVENT FROM THE SAME CUSTOMER WHICH OCCURRED ON A DIFFERENT DATE. THE RELATED MEDWATCH REPORT NUMBER IS 2050012-2011-04076.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT ERRONEOUSLY LOW TOTAL BILIRUBIN (TBIL) RESULTS FOR SEVERAL PATIENT SAMPLES ASSAYED ON A SYNCHRON LX20 PRO CLINICAL CHEMISTRY SYSTEM. THE ERRONEOUS TBIL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED THAT QUALITY CONTROL (QC) RESULTS WERE RECOVERING WITHIN THE LABORATORY'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. THE CUSTOMER REPORTED THAT THE TBIL RESULTS FOR SOME PATIENT SAMPLES WERE 0.2 AND 0.3 UMOL/L. WHEN REASSAYED ON THE LABORATORY'S OTHER ANALYZER, THE PATIENT SAMPLES YIELDED HIGHER TBIL RESULTS. THESE HIGHER TBIL RESULTS WERE INTERPRETED TO BE CORRECT AND WERE REPORTED OUTSIDE OF THE LABORATORY. SPECIFIC DATA HAS BEEN REQUESTED FROM THE CUSTOMER, BUT HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX®20 PRO CLINICAL CHEMISTRY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. LX®20 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1 TOTAL BILIRUBIN REAGENT