BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2624713 · Received June 21, 2012

    Report

    Report Number
    2122870-2012-01498
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    May 22, 2012
    Report Date
    May 23, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    NBC
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE PATIENT'S SAMPLE WAS A SHORT DRAW FROM AN EDTA TUBE AND SPUN DOWN FOR 10 MINUTES AT 3200 RPMS. THE CUSTOMER ALSO INDICATED THAT ALL SYSTEM CHECKS PRIOR TO THE EVENT WERE WITHIN THE SPECIFIED PARAMETERS. QC RESULTS WERE ALSO WITHIN THE LABORATORY'S EXPECTED RANGE. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND DISCOVERED A FLUID LEAK IN THE SUBSTRATE MANIFOLD. THE FSE REPLACED THE SUBSTRATE MANIFOLD AND CLEANED THE WASH WHEEL. THE FSE ALSO PERFORMED PIPETTOR ALIGNMENTS AND PRIMED THE SYSTEM. VALIDATION TESTING WAS PERFORMED ON BOTH THE INSTRUMENT AND THE CTA (CLOSED TUBE ALIQUOTER), WHICH NO FURTHER ISSUES WERE NOTED. ALTHOUGH HARDWARE MAY HAVE BEEN A CONTRIBUTING FACTOR, PRE-ANALYTICAL ISSUES MAY ALSO HAVE CONTRIBUTED TO THE LOW BNP2 RESULT. A DEFINITIVE CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING AN ERRONEOUSLY LOW B-TYPE NATRIURETIC PEPTIDE (BNP2) RESULT OF 1 PG/ML GENERATED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER DECIDED TO REANALYZE THE SAMPLE DUE TO SOME REOCCURRING ISSUES WITH OTHER ERRONEOUS RESULTS, WHICH IS DOCUMENTED IN MDR 2122870-2012-01482. SUBSEQUENT TESTING PRODUCED A BNP2 RESULT OF 127 PG/NL. THE ERRONEOUS BNP2 RESULT WAS NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT AFFECTED AS A RESULT OF 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 NBC BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1