BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2792390 · Received October 16, 2012

    Report

    Report Number
    2122870-2012-01823
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    Z-0607-2011
    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. OPERATOR ERROR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    AS PART OF BECKMAN COULTER MARKETING SURVEY PROGRAM (MSP), THE CUSTOMER REPORTED ONE ERRONEOUS TROPONIN I (ACCESS ACCUTNI) RESULT, FOR ONE PATIENT, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. IT WAS DETERMINED THE CUSTOMER INCORRECTLY LOADED THE REAGENT PACK ONTO THE REAGENT CAROUSEL. THE CUSTOMER STATED THE ERRONEOUS RESULT WAS RELEASED OUT OF THE LABORATORY. THERE HAS BEEN NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1