BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRON LXI 725 SYSTEM

    MDR report key: 2499131 · Received March 21, 2012

    Report

    Report Number
    2122870-2012-00800
    Event Type
    Injury
    Date Received
    March 21, 2012
    Date of Event
    March 3, 2012
    Report Date
    March 3, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2012 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE WASH PUMP SEAL AND O-RING, CLEANED THE WASH VALVE AND VERIFIED THE ULTRASONIC SETTINGS. THE FSE ALSO REPLACED THE SUBSTRATE PROBE, ASPIRATE PROBES AND ASSOCIATED TUBING. THE FSE PERFORMED A ROUTINE SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK BOTH OF WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. AFTER COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED INTO OPERATION. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2012, AN ERRONEOUSLY ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULT WAS GENERATED ON A SYNCHRON LXI 725 SYSTEM FOR ONE PATIENT SAMPLE. THE ELEVATED ACCUTNI RESULT WAS RELEASED FROM THE LABORATORY, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL BASED UPON THE RESULT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT SUBSEQUENT REPEAT TESTING AND A REDRAW OF THE PATIENT GENERATED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE FROM THE ORIGINAL INSTRUMENT AS WELL AS ANOTHER INSTRUMENT. THE REPEAT/REDRAWN RESULTS WERE REGARDED AS VALID. SAME-SAMPLE CREATINE KINASE-MB ISOENZYME (CK-MB) RESULTS WERE ELEVATED BUT WERE NOT QUESTIONED BY THE CUSTOMER. THE SAMPLES WERE COLLECTED IN PLASTIC LITHIUM HEPARIN (LIHEP) PLASMA TUBES WITH GEL SEPARATORS AND CENTRIFUGED AT AMBIENT TEMPERATURE PRIOR TO TESTING. THE ORIGINAL SAMPLE WAS A FULL DRAW AND WITHOUT ANY SAMPLE QUALITY ISSUES NOTED. THE ORIGINAL SAMPLES WERE STORED AT ROOM TEMPERATURE FOR SIX HOURS AND THEN REFRIGERATED. THE ORIGINAL RESULT WAS OBTAINED FROM AN ALIQUOT PLACED WITHIN A NESTED INSERT CUP WITHIN THE PRIMARY TUBE. ACCUTNI QUALITY CONTROL (QC) VALUES WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. A ROUTINE SYSTEM CHECK PERFORMED AFTER THE EVENT GENERATED RESULTS WHICH MET INSTRUMENT SPECIFICATIONS. NO OTHER PATIENTS' RESULTS WERE QUESTIONED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LXI 725 SYSTEM ANALYZER, CHEMISTRY MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization ACCESS ACCUTNI REAGENT