BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    MDR report key: 1594515 · Received February 4, 2010

    Report

    Report Number
    2050012-2010-00033
    Event Type
    Malfunction
    Date Received
    February 4, 2010
    Date of Event
    January 11, 2010
    Report Date
    February 4, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON TROUBLESHOOTING THE CUSTOMER DISCOVERED THE REAGENT SYRINGE WAS LOOSE WHERE IT CONNECTS TO THE T-VALVE. PER CUSTOMER, MAINTENANCE TO THESE PARTS HAD NOT BEEN PERFORMED RECENTLY. SERVICE REPLACED THE SYRINGE AND THE T-VALVE. UPON RECUR, THE ISSUE COULD AFFECT OTHER CHEMISTRIES INCLUDING POTENTIALLY PIVOTAL CHEMISTRIES, AND TREATMENT COULD BE INITIATED OR WITHHELD BASED UPON THE ERRONEOUS RESULT. A CLEAR ROOT CAUSE IS NOT KNOWN AT THIS TIME. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A SUPPRESSED MAGNESIUM (MG) RESULT GENERATED BY THE SYNCHRON LX20 PRO CLINICAL SYSTEM. THE INITIAL "SUPPRESSED OIR LO" MG RESULT WAS INTERPRETED TO BE <0.1 MG/DL AND REPORTED OUT AS 0.1 MG/DL. THE SPECIMEN WAS TESTED ON A DIFFERENT INSTRUMENT AND OBTAINED RESULT WAS "SUPPRESSED OIR HI". THE SPECIMEN WAS DILUTED 1:2, AND THEN RETESTED AND MG RESULT WAS 7.8 MG/DL (INSTRUMENT UNKNOWN) THE PATIENT WAS REDRAWN AND THE SAMPLE WAS TESTED ON THE LX20 ANALYZER WHICH GENERATED A "SUPPRESSED OIR HI" RESULT. THE REDRAWN SAMPLE WAS DILUTED 1:3 AND RE-TESTED, AND A RESULT OF 8.1 MG/DL WAS GENERATED. (INSTRUMENT UNKNOWN) THE RESULT WAS AMENDED. THERE WAS NO EFFECT TO THE PATIENT. THE ERRONEOUS RESULT WAS FOR A LABORING PATIENT RECEIVING A MG DRIP, AND THE LOW RESULT WAS NOT BELIEVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1