BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2192405 · Received August 5, 2011

    Report

    Report Number
    2122870-2011-02696
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 3, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SERUM, COLLECTED IN A 13X100 MM GRAINER VACUETTE, AND CENTRIFUGED AT 4100G FOR TEN (10) MINUTES AT ROOM TEMPERATURE. THE CUSTOMER INDICATED THAT UPON VISUAL INSPECTION, THE SAMPLE LOOKED CLEAR AND FULL VOLUME. PER THE CUSTOMER COMPLAINT RECORDS, QC WAS WITHIN CUSTOMER'S ESTABLISHED RANGES. THE CUSTOMER ALSO HAD A PASSING ACCUTNI CALIBRATION ON (B)(4) 2011. THE CUSTOMER'S LAST SYSTEM CHECK WAS WITHIN SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO OBTAINING A TROPONIN (ACCUTNI) RESULT ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF FOR ONE (1) PATIENT'S SAMPLE, GENERATED BY THE UNICEL DXC 600I ACCESS IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. UPON REPEAT, THE RESULT WAS WITHIN THE RISK STRATIFICATION RANGE. 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 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1