BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2296776 · Received October 14, 2011

    Report

    Report Number
    2122870-2011-04560
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    September 14, 2011
    Report Date
    September 15, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE DRAWN IN BECTON DICKINSON LITHIUM HEPARIN PLASMA GEL SEPARATOR TUBES. THE SPECIMENS WERE SPUN FOR 10 MINUTES IN A SWINGING BUCKET CENTRIFUGE AT 3,000 RPM. THE SAMPLES WERE PROCESSED THROUGH THE CLOSED TUBE ALIQUOTER (CTA). A PREVENTIVE MAINTENANCE (PM) HAD BEEN COMPLETED ON (B)(4) 2011. QC HAD BEEN WITHIN SPECIFICATIONS PRIOR TO THIS EVENT. QC WAS PERFORMED AFTER THE EVENT. LEVEL I QC FAILED FOR ACCUTNI AND MYOGLOBIN. THE CUSTOMER REPORTED MULTIPLE WASH VALVE/PUMP MOTION ERRORS AT THIS TIME. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE REPLACED LEAKING WASH PUMP SEALS, THE WASH VALVE ROTOR AND STATOR. THE FSE CONDUCTED A SUCCESSFUL SYSTEM CHECK. DIAGNOSTIC TESTS WERE PERFORMED INDICATING SATISFACTORY SYSTEM PERFORMANCE. THIS EVENT IS ATTRIBUTED TO HARDWARE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC), AND STATED THAT PATIENT SAMPLES WERE TESTED FOR TROPONIN (ACCUTNI) AND CREATINE KINASE MB (CKMB) ON UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM AND MULTIPLE RESULTS WERE QUESTIONED BY THE ER. THE CUSTOMER REPEATS ALL POSITIVE ACCUTNI RESULTS. IT RECOVERED LOWER, BUT STILL POSITIVE. THE SAMPLES WERE RUN ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND ALL RESULTS RECOVERED WITHIN THE NORMAL RANGE. PATIENT RESULTS ARE PROVIDED. PER THE SUPPLEMENTAL DATA FORM, AT LEAST ONE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THESE RESULTS. NO REPORTS OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR FURTHER CHANGE TO PATIENT TREATMENT WERE ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization