BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1702542 · Received May 28, 2010

    Report

    Report Number
    2122870-2010-00220
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 28, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JHS
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE SERUM COLLECTED IN SST TUBES AND CENTRIFUGED FOR 10 MINUTES AT 3000 RPM. QC WAS WITHIN ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. SYSTEM CHECK PERFORMED ON (B)(4) 2010 WAS WITHIN INSTRUMENT SPECIFICATIONS A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE (B)(4) 2010. FSE REPLACED THE INCUBATOR BELT AND CLIPS, CLEANED THE WASH CAROUSEL AND VERIFIED THE ALIGNMENTS AND ULTRASONICS. NO HARDWARE ISSUES WERE NOTED. A SYSTEM CHECK AND QC WERE PERFORMED AND WERE WITHIN SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A CKMB RESULT ABOVE THE NORMAL REFERENCE RANGE GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT. UPON REPEAT THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1