BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3103670 · Received May 9, 2013

    Report

    Report Number
    2122870-2013-00442
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 3, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERRONEOUS TROPONIN I (ACCESS ACCUTNI) RESULT, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, FOR ONE PATIENT, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM USED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY. SUBSEQUENT TESTING OF THE PATIENT'S SAMPLE, ON AN ALTERNATE UNICEL DXC 600I SYSTEM, RECOVERED A LOWER RESULT WITHIN THE RISK STRATIFICATION RANGE. THE ERRONEOUS RESULT WAS NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER HAS A SAMPLE REPEAT PROTOCOL TO REANALYZE ANY RESULT GREATER THAN 0.6 NG/ML THAT HAS NO PREVIOUS SAMPLE HISTORY. THE CUSTOMER STATED THE SAMPLE WAS PLASMA AND INITIALLY CENTRIFUGED FOR THREE MINUTES AND DID NOT RE-CENTRIFUGE PRIOR TO REANALYSIS. THE EVENT WAS REPORTED AS PART OF BECKMAN COULTER MARKETING SURVEY PROGRAM (MSP) FOR ACCESS ACCUTNI). THE CUSTOMER DID NOT PROVIDE ANY INFORMATION INDICATING AN INCREASE IN OCCURRENCE OR AN INSTRUMENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203726 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 86 YR