BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX®I 725 CLINICAL SYSTEM

    MDR report key: 2180337 · Received July 27, 2011

    Report

    Report Number
    2122870-2011-02551
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS COLLECTED IN A GREEN TOP LITHIUM HEPARIN PLASMA TUBE WITH GEL SEPARATOR AND CENTRIFUGED FOR 4 MINUTES AT 3800RPM. SYSTEM CHECKS ON THE DAY OF THE EVENT PASSED WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE (B)(4) 2011. SEVERAL REPAIRS WERE COMPLETED ON THE ACCESS 2 ANALYTICAL MODULE AND THE FSE PERFORMED VERIFICATION TESTING AFTER REPAIRS WERE COMPLETED. FSE OBSERVED SEVERAL FLIERS FROM A HIGH SENSITIVITY SYSTEM CHECK AND THE FSE DETERMINED THAT FURTHER REPAIRS WERE NEEDED. FSE REPLACED INCUBATOR BEARINGS AND PULLEYS BUT THE VERIFICATION ASSAY FLIERS WERE STILL OCCURRING SO THE FSE CONTINUED REPAIRS. FSE CONSULTED WITH TECHNICAL SUPPORT TO DETERMINE THAT A NEW ANALYTICAL MODULE WAS REQUIRED AND THE MODULE WAS ORDERED. FSE REPLACED THE ANALYTICAL MODULE AND CONTINUED TO TROUBLESHOOT THE ISSUE WITH TECHNICAL SUPPORT AFTER STILL SEEING ISSUES FROM SYSTEM CHECK ASSAYS. FSE REPLACED MIXER ROLLER AND PINCH ROLLER ASSEMBLIES, THE MIXER BELT, PERI PUMP TUBING AND CLEANED OUT THE INCUBATOR BELT TRACK AND WASH CAROUSEL. FSE ALSO REBUILT THE WASH PUMP, PRECISION PUMP AND REPLACED THE TIMING BELTS FOR BOTH PUMPS AFTER NOTING THAT THEY WERE SLIGHTLY CRACKED. FSE ALSO PERFORMED SOME ALIGNMENTS AND MIXER SPEED ADJUSTMENTS AFTER REPLACING AND REBUILDING SEVERAL HARDWARE COMPONENTS AND AFTER COMPLETING ALL REPAIRS, FSE PERFORMED A PASSING SYSTEM CHECK WITHIN INSTRUMENT SPECIFICATIONS AND A PASSING HIGH SENSITIVITY SYSTEM CHECK WITHIN INSTRUMENT SPECIFICATIONS ALTHOUGH EXTENSIVE REPAIRS WERE COMPLETED BY THE FSE, A DEFINITIVE MALFUNCTION WAS NOT DETECTED DURING INSTRUMENT SERVICE AND A DEFINITIVE ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ELEVATED TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY BUT WAS QUESTIONED BY THE PHYSICIAN AND REPEAT TESTING WAS PERFORMED WHICH PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT REPORT ANY PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1