BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3011825 · Received March 19, 2013

    Report

    Report Number
    2122870-2013-00312
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE [FIELD SERVICE ENGINEER] SERVICED THE INSTRUMENT ON 02/19/2013 AND NOTED A BROKEN SERVICE LOOP CHAIN AND REPLACED THE LOOP CHAIN. THE FSE COMPLETED SYSTEM CHECK FOLLOWING SERVICE AND ALL PORTIONS PASSED WITHIN SERVICE SPECIFICATION. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. THE CUSTOMER INDICATED THE PATIENT ALSO HAD A CARDIAC PANEL PERFORMED AND OBTAINED A CREATINE KINASE-MB (CK-MB) RESULT OF 6.7 NG/ML WHICH WAS ABOVE THE REFERENCE RANGE OF THE ASSAY. QUALITY CONTROL (QC) FOR ALL THREE LEVELS WERE WITHIN THE ACCEPTABLE RANGE ON THE DAY OF THE EVENT. PATIENT SAMPLES WERE COLLECTED IN SERUM SEPARATION TUBES (SST) AND CENTRIFUGED AT 4,000 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT TROPONIN I (ACCESS ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, FOR ONE PATIENT, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM USED IN CONJUNCTION WITH ACCESS ACCUTNI ASSAY AND CALIBRATOR. THE CUSTOMER-SUPPLIED DATA INDICATED AN INITIAL TROPONIN I RESULT OF 8.35 NG/ML WAS OBTAINED. PER LABORATORY PROTOCOL, THE SAMPLE WAS REANALYZED ON THE SAME INSTRUMENT AND PRODUCED A SIMILAR ELEVATED RESULT. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL BASED ON THE ELEVATED RESULTS. A SERIAL DRAW WAS OBTAINED FROM THE PATIENT AND THE SAMPLE WAS REANALYZED THE FOLLOWING DAY, WHICH PRODUCED A NEGATIVE RESULT. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AND REQUESTED THE SAMPLE BE REANALYZED WHICH RECOVERED A LOWER VALUE OF 0.02 NG/ML, WITHIN THE NORMAL REFERENCE RANGE. AN AMENDED REPORT WAS ISSUED TO THE PHYSICIAN. THE CUSTOMER HAS NOT RECEIVED ANY REPORTS OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AT THE CUSTOMER'S FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113772 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Hospitalization