BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1630872 · Received March 15, 2010

    Report

    Report Number
    2122870-2010-00094
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    February 16, 2010
    Report Date
    March 15, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MXZ
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A RED TOP CORVAC TUBE WITH GEL, AND WAS SAMPLED FROM THE PRIMARY TUBE. QC WAS WITHIN SPECIFICATIONS PRIOR TO THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED A DIAGNOSTIC TESTING WHICH MET SPECIFICATIONS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED ERRONEOUSLY LOW PROGESTERONE RESULTS ON ONE PATIENT. THE TECH QUESTIONED THE RESULTS AND RAN THE SAMPLE ON A DIFFERENT INSTRUMENT WHICH GAVE A RESULT OF 0.71NG/ML. THE RESULT WAS REPORTED OUT OF THE LAB. CUSTOMER THEN RECALIBRATED PROGESTERONE ASSAY ON THE DXI 800 ANALYZER. PROGESTERONE TESTING WAS REPEATED, AND A RESULT OF 0.49NG/ML WAS OBTAINED. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. 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® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MXZ BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1