BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2508418 · Received March 29, 2012

    Report

    Report Number
    2122870-2012-00812
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    February 23, 2012
    Report Date
    February 29, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LOM
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SENT THE SAMPLE TO CUSTOMER PRODUCT LINE SERVICE (CPLS) FOR INVESTIGATIVE TESTING. THE CPLS RESULTS AND CONCLUSION ARE: SAMPLE WAS FOUND REACTIVE ON SCREENING HBSAG ASSAY (23.1 S/CO). SAMPLE WAS CONFIRMED ON THE HBSAG CONFIRMATORY ASSAY WITH A HBSBK SIGNAL ABOVE 40%. HETEROPHILE TESTING DEMONSTRATED THE PRESENCE OF INTERFERING SUBSTANCES LEADING TO A FALSELY REACTIVE HBSAG RESULT SINCE AT LEAST ONE OF THE HETEROPHILE BLOCKERS USED IN THE TEST SIGNIFICANTLY LOWERED THE SIGNAL. OTHER TEXT: SERVICE WAS NOT DISPATCHED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING FALSELY REACTIVE HBSAG RESULTS FOR ONE PATIENT SAMPLE GENERATED ON THE DXI 800 PORTION OF THE UNICEL DXC 880I ACCESS CLINICAL SYSTEM USED IN CONJUNCTION WITH THE ACCESS HBSAG REAGENT KIT (LOT # 192336). THE CUSTOMER CONFIRMED THE POSITIVE RESULTS ON THE HBSAG CONFIRMATORY ASSAY. THE RESULT WAS REPORTED OUT OF THE LABORATORY; HOWEVER, THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. THE CUSTOMER SENT OUT THE PATIENT SAMPLE FOR TESTING TO TWO ALTERNATE LABORATORIES TO BE TESTED ON ALTERNATE METHODOLOGY. THE CUSTOMER REPORTED TESTING ON ROCHE AND ABBOTT METHODOLOGIES PRODUCED 'NEGATIVE' RESULTS ON BOTH METHODS. THE SAMPLES WERE SERUM, WHICH WERE FROZEN AND THAWED PRIOR TO ANALYSIS. THE CUSTOMER DID NOT PROVIDE SYSTEM CHECK DATA. PER CUSTOMER, THE QC WAS PERFORMING WITHIN THE ESTABLISHED LIMITS ON THE DATE OF THE EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE LOM BECKMAN COULTER INC. DXI 600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1