BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2199881 · Received August 10, 2011

    Report

    Report Number
    2122870-2011-02686
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 11, 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
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLE WAS COLLECTED IN A GOLD TOP SERUM TUBE, CENTRIFUGED FOR 5 MINUTES AT 3800 RPM. PER THE CUSTOMER SUPPLIED QC CHARTS, BOTH LEVEL 2 AND LEVEL 3 TBHCG QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND ON THE DAY OF THE EVENT. LEVEL 1 QC DATA FOR THE TIMEFRAME OF THE EVENT HAS NOT BEEN SUPPLIED TO DATE. ADDITIONAL SYSTEM INFORMATION HAS ALSO NOT BEEN SUPPLIED TO DATE. ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE INSPECTED THE INSTRUMENT; NO ISSUES WERE NOTED. THE FSE PERFORMED A DILTEST AND DILAP TEST FOR DILUTION TESTS AND ULTRASONICS; BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE PERFORMED A TWELVE REPLICATE PRECISION TEST USING POOLED SERUM FOR BOTH REAGENT PIPETTORS; RESULTS WERE WITHIN THE STATED PRECISION CLAIMS OF THE ASSAY AT <10%. A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING IMPRECISE POSITIVE TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (THCG) FOR ONE (1) PATIENT. THE RESULT WAS GENERATED BY A UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH ACCESS THCG REAGENT (LOT 021722) AND ACCESS THCG CALIBRATORS (LOT 017956). THE RESULTS OBTAINED WERE OUTSIDE OF THE ASSAY'S STATED PRECISION CLAIMS OF <10%. 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 SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE DHA BECKMAN COULTER, INC. DXI 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1