BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1962175 · Received January 17, 2011

    Report

    Report Number
    2050012-2011-00051
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS PERFORMED BEFORE THE EVENT AND RESULTS WERE WITHIN ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REPLACED THE WASH COLLAR AND SAMPLE PROBE. BCI FOLLOWED-UP WITH THE CUSTOMER ON (B)(6) 2010, AND THE CUSTOMER STATED THAT QC RESULTS GENERATED ON THIS INSTRUMENT ARE CONSISTENT AND WITHIN ESTABLISHED RANGES. ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT SYNCHRON LXI 725 CLINICAL SYSTEM GENERATED DIGOXIN (DIGN) RESULTS OF <0.2NG/ML AND THE CUSTOMER DID NOT BELIEVE IN THE RESULTS. THE CUSTOMER DILUTED THE SAMPLE WITH DRUG CAL II, LEVEL 4, BUT THE RESULTS DID NOT MATCH PER CALCULATION. THE CUSTOMER SENT THE SAMPLES OUT TO ANOTHER LAB FOR CONFIRMATION AND GENERATED RESULTS WERE HIGHER AND WERE REPORTED OUT OF THE LAB. THE LOW RESULTS WERE NOT REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1