BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2013496 · Received March 10, 2011

    Report

    Report Number
    2122870-2011-00541
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THEY HAVE A PROCEDURE IMPLEMENTED TO VERIFY UNEXPECTED RESULTS PRIOR TO REPORTING RESULTS OUTSIDE THE LABORATORY. PER CUSTOMER, THE UNIT WAS PERFORMING WITHIN QC SPECIFICATIONS. THE CUSTOMER DECLINED SUBMITTING SPECIFIC DATA.

    Description of Event or Problem · 1

    BECKMAN COULTER INC (BCI) CONTACTED THIS CUSTOMER VIA THE TROPONIN (ACCUTNI) MARKETING SURVEY PROGRAM (MSP) CUSTOMER CONTACT PROGRAM. THE CUSTOMER INDICATED SOME OCCURRENCES OF NON-REPRODUCIBLE FALSE POSITIVE ACCUTNI PATIENT RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT REPORT AFFECT TO THE PATIENT OR USER ATTRIBUTED OR CONNECTED TO 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 MMI BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1