BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2200533 · Received August 11, 2011

    Report

    Report Number
    2122870-2011-02853
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION DEVICE AND CENTRIFUGATION INFORMATION HAS NOT BEEN PROVIDED. QC IS PERFORMING WITHIN THE ESTABLISHED RANGES. SYSTEM CHECK DATA HAS NOT BEEN PROVIDED. A NEW LOT OF REAGENT WAS SENT TO THE CUSTOMER. ANALYSIS DID NOT SHOW A REAGENT ISSUE. BEC WOULD RECOMMEND TO THE CUSTOMER, IN CASE OF SIMILAR ISSUE, TO TRANSFER THE SAMPLE FROM THE ORIGINAL TUBE AND RE-CENTRIFUGED PRIOR TO RE-TEST. AFTER CENTRIFUGATION SAMPLE SHOULD BE HANDLED CAREFULLY TO AVOID CELLULAR DEBRIS RE-SUSPENSION THAT MAY INTERFERE WITH THE ASSAY. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) CONCERNING AN ERRONEOUSLY ELEVATED TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT ABOVE THE NORMAL REFERENCE RANGE GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE 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 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CLINICAL CHEMISTRY ANALYZER DHA BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1