BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 860921 · Received May 2, 2007

    Report

    Report Number
    2122870-2007-00100
    Event Type
    Other
    Date Received
    May 2, 2007
    Date of Event
    April 3, 2007
    Report Date
    May 2, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JHI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. SYSTEM CHECK PERFORMED IN 2007, PARTIALLY FAILED DUE TO A QNS ON THE LAST REPLICATE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB ON THE SAME DAY. THE FSE PERFORMED DIAGNOSTIC TESTING WHICH PASSED WITHIN SPECIFICATIONS. THE FSE CONDUCTED CARRYOVER TEST WHICH MET SPECIFICATIONS. THE FSE VERIFIED INSTRUMENT PER ESTABLISHED PROCEDURES. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING A FALSE NEGATIVE (-) TOTAL BHCG (TBHCG) RESULT FROM A SINGLE PATIENT SAMPLE THAT WAS GENERATED BY THE UNICEL DXL 800 ACCESS INSTRUMENT. A PATIENT SAMPLE WAS TESTED FOR TBHCG AND A RESULT OF 0.00MLU/ML WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB AND QUESTIONED BY A PHYSICIAN. THE CUSTOMER COLLECTED A FRESH SAMPLE FROM THE PATIENT AND TESTED FOR TBHCG; THE RESULT WAS 6300MLU/ML WHICH MATCHED THE CLINICAL PICTURE OF THE PATIENT. (PRINTOUT FOR THIS RESULT WAS NOT SUPPLIED). THE CUSTOMER THEN RE-TESTED THE ORIGINAL SAMPLE FOR TBHCG) AND THE REPEATED RESULT WAS 5723.0MLU/ML. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA