BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2131253 · Received June 16, 2011

    Report

    Report Number
    2122870-2011-01902
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER USES LITHIUM HEPARIN PLASMA TUBES. PER THE OUTSIDE LAB, ANTIBODY INTERFERENCE FOR THIS SAMPLE WAS FOUND ON THEIR "UNKNOWN" METHODOLOGY. IT IS UNKNOWN IF THIS INTERFERENCE WOULD HAVE ANY IMPACT ON A BCI ASSAY. SAMPLE WAS UNAVAILABLE FOR FURTHER TESTING. CUSTOMER HAS A PRO-ACTIVE PROCEDURE TO REPEAT ALL FIRST-TIME POSITIVE ACCUTNI RESULTS (>0.49NG/ML). SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE. NO CLEAR ROOT CAUSE HAS BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI), AND STATED THAT THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED A FALSE POSITIVE TROPONIN (ACCUTNI) RESULTS FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB. A PHYSICIAN CALLED THE LAB TO QUESTION THE RESULT DUE IT NOT FITTING THE CK-MB RESULT OR THE CLINICAL PICTURE OF THE PATIENT. THE SPECIMEN WAS SENT TO OUTSIDE LABORATORY FOR TESTING AND THE RESULT WAS "NEGATIVE". PER CUSTOMER STATEMENT, THERE WAS NO DEATH, INJURY, SERIOUS MEDICAL DETERIORATION OR INAPPROPRIATE MEDICAL TREATMENT ASSOCIATED 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 JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1