BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1644240 · Received March 30, 2010

    Report

    Report Number
    2122870-2010-00119
    Event Type
    Malfunction
    Date Received
    March 30, 2010
    Date of Event
    February 12, 2010
    Report Date
    March 30, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MXZ
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION, QC, AND MAINTENANCE INFORMATION WAS NOT SUPPLIED. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED LOWER THAN EXPECTED RESULTS FOR PROGESTERONE FOR ONE PATIENT. ONE SAMPLE WAS REPEATED ON A DIFFERENT REAGENT LOT AND PROGESTERONE RESULTS RECOVERED MUCH HIGHER, WITHIN A DIFFERENT DIAGNOSTIC REFERENCE RANGE. THE RESULTS WERE REPORTED OUT OF THE LAB. BASED ON AVAILABLE INFORMATION, THE PATIENT WAS GIVEN AN INJECTION OF PROGESTERONE DUE TO THE LOWER THAN EXPECTED PROGESTERONE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MXZ BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1