BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 4954066 · Received July 30, 2015

    Report

    Report Number
    2122870-2015-00455
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 11, 2015
    Report Date
    July 12, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE. THE FSE COMPLETED PREVENTATIVE MAINTENANCE (PM) ON THE INSTRUMENT WHICH INCLUDES THE REPLACEMENT OF SEVERAL HARDWARE COMPONENTS. AFTER COMPLETION OF THE PM ALL VERIFICATION TESTING PASSED WITHIN PUBLISHED INSTRUMENT AND ASSAY PERFORMANCE SPECIFICATIONS. IN CONCLUSION, THE CAUSE OF THE ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS IS DUE TO A SYSTEM MALFUNCTION, ALTHOUGH NO ONE PART CAN BE IMPLICATED AS THE SOLE CONTRIBUTOR IN THIS EVENT. A PM WAS PERFORMED ON THE INSTRUMENT AND MULTIPLE PARTS WERE EITHER SERVICED OR REPLACED WHICH THEN CORRECTED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS IN ASSOCIATION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM SERIAL NUMBER 800730 FOR THREE (3) PATIENTS. THERE IS NO INDICATION THAT THE CUSTOMER REANALYZED THE SAMPLES FOR THE THREE (3) PATIENTS. THE ELEVATED ACCESS ACCUTNI+3 RESULTS FOR THE THREE (3) PATIENTS WERE REPORTED FROM THE LAB AND QUESTIONED BY A PHYSICIAN. THERE WAS NO REPORTED CHANGE OR IMPACT TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN ASSOCIATION WITH THE ELEVATED ACCESS ACCUTNI+3 RESULTS OBTAINED BY THE CUSTOMER. QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE LABORATORY ESTABLISHED RANGES PRIOR TO THE EVENT. AFTER OBTAINING THE ELEVATED ACCESS ACCUTNI+3 RESULTS THE CUSTOMER REANALYZED ASSAY QC. THE QC RESULTS OBTAINED FOR THE ACCESS ACCUTNI+3 LEVEL 1 QC WAS ABOVE THE LABORATORY'S ESTABLISHED RANGES. THE CUSTOMER ALSO ATTEMPTED MULTIPLE ACCESS ACCUTNI+3 CALIBRATIONS WHICH FAILED AFTER OBTAINING THE ELEVATED ACCESS ACCUTNI+3 RESULTS. THE CUSTOMER DID NOT PROVIDE ANY SPECIMEN OR COLLECTION INFORMATION SUCH AS SAMPLE TYPE OR CENTRIFUGATION DATA. THE CUSTOMER DID NOT NOTE ANY SAMPLE INTEGRITY ISSUES. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498299 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1