BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 1900760 · Received November 16, 2010

    Report

    Report Number
    2122870-2010-00754
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES ON THE DAY OF THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(6) 2010 FOR THIS EVENT. THE FSE PERFORMED A SYSTEM CHECK AND 20 REPETITIONS OF LEVEL 1 QC SAMPLE. ALL TEST RESULTS MET THE SPECIFICATIONS. NO HARDWARE ISSUE WAS NOTED. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A HIGHER THAN EXPECTED PROGESTERONE RESULT GENERATED BY UNICEL DXI 600 ACCESS IMMUNOASSAY ANALYZER ON ONE PATIENT SAMPLE. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND WAS QUESTIONED BY THE PHYSICIAN. SUBSEQUENT TESTING ON THE SAME INSTRUMENT AND ON AN ALTERNATE INSTRUMENT PRODUCED RESULTS IN A LOWER CLINICAL RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 600 ACCESS® IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1