BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM.

    MDR report key: 2840986 · Received November 20, 2012

    Report

    Report Number
    2122870-2012-01920
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL SYSTEM PARAMETERS (INCLUDING QC, CALIBRATION, AND SYSTEM CHECKS) WERE PERFORMING WITHIN ASSAY/INSTRUMENT SPECIFICATIONS. THE CUSTOMER CONFIRMED THERE WERE NO ERRORS IN THE ANALYZER'S EVENT LOG AT THE TIME OF TESTING. THE CUSTOMER REPORTED THE PATIENT SAMPLE WAS A FULL DRAW COLLECTED BY EMERGENCY DEPARTMENT PERSONNEL INTO LITHIUM HEPARIN PLASMA TUBES WITHOUT A GEL SEPARATOR, WAS NORMAL IN APPEARANCE, WAS CENTRIFUGED IN A STAT SPIN CENTRIFUGE (CENTRIFUGATION SPEED AND TIME WERE NOT SUPPLIED BY THE CUSTOMER), AND WAS ANALYZED FROM THE PRIMARY TUBE THROUGH THE ANALYZER'S CLOSED TUBE ALIQUOTTER (CTA). A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012 TO THE CUSTOMER SITE TO VERIFY HARDWARE PERFORMANCE IN RESPONSE TO THIS EVENT. THE FSE PERFORMED A MODIFICATION TO REPLACE THE PERISTALTIC PUMP CASSETTE WHILE ONSITE. THE FSE ALSO NOTED "FOAMING" IN THE WASH PUMP WHILE PRIMING THE DISPENSE PROBES AND THE WASH VALVE ROTOR WAS REPLACED TO ADDRESS THE "FOAMING". THE FSE THEN PERFORMED A SYSTEM CHECK, WHICH WAS PASSING WITHIN INSTRUMENT SPECIFICATIONS; HOWEVER, THE FSE NOTED "FLIERS" AND PROACTIVELY REPLACED THREE MIXERS AND REBUILT THE WASH AND PRECISION PUMPS. THE FSE ALSO FOUND 5 BENT INCUBATOR BELT CLIPS WHICH WERE REPLACED. ALL ALIGNMENTS WERE VERIFIED AND A (B)(4) WAS THEN PERFORMED; ALL RESULTS WERE WITHIN ASSAY SPECIFICATIONS. IN CONCLUSION, A HARDWARE MALFUNCTION IS THE LIKELY CAUSE OF THE EVENT. THE FSE NOTED "FOAMING" IN THE WASH PUMP WHICH MAY HAVE LED TO THE INCORRECT AMOUNT OF WASH BUFFER DISPENSED INTO THE RVS LEADING TO POOR WASHING OF THE UNBOUND ANALYTE AND DOSE OVER-RECOVERY OF THE ASSAY. THE FSE ALSO NOTED IMPRECISION DUE TO BENT INCUBATOR BELT CLIPS AND INDICATED THAT THEY WERE BENT ENOUGH TO CAUSE SPLASHING WITHIN THE RVS WHEN THE RVS WERE MOVING BETWEEN THE INCUBATOR TROUGH AND THE WASH CAROUSEL, WHICH MAY HAVE CAUSED POOR WASHING/INCOMPLETE ASPIRATION OF THE UNBOUND ANALYTE AND DOSE-OVER RECOVERY OF THE ASSAY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF ON ONE (1) PATIENT GENERATED ON THE UNICEL DXC 600I ACCESS IMMUNOASSAY SYSTEM FROM THE HOSPITAL'S EMERGENCY DEPARTMENT. AN INITIAL ACCUTNI RESULT OF 3.54 NG/ML WAS OBTAINED AND WAS RELEASED OUTSIDE THE LABORATORY. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE ERRONEOUSLY ELEVATED ACCUTNI RESULT. THE PATIENT'S SAMPLE WAS THEN REPEATED ON THE LABORATORY'S ALTERNATE INSTRUMENT AND A LOWER ACCUTNI RESULT OF 0.02 NG/ML, WITHIN THE NORMAL REFERENCE RANGE, WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM. ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization