BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2853469 · Received November 30, 2012

    Report

    Report Number
    2122870-2012-01916
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THE PATIENT SAMPLE WAS COLLECTED INTO A LITHIUM HEPARIN PLASMA TUBE AND WAS NOT HEMOLYZED, ICTERIC, OR LIPEMIC. NO ADDITIONAL SAMPLE INFORMATION WAS PROVIDED. BEC CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER THAT THE PATIENT SAMPLE COULD BE SENT TO BECKMAN COULTER FOR PATIENT SOURCE INTERFERENT TESTING; HOWEVER, THE CUSTOMER DECLINED TO SEND THE PATIENT SAMPLE FOR TESTING. ALL SYSTEM PARAMETERS (INCLUDING QC, CALIBRATION CURVE, AND SYSTEM CHECKS) WERE PERFORMING WITHIN ASSAY/INSTRUMENT SPECIFICATIONS. IN CONCLUSION, UPON REVIEW OF ALL SUPPLIED DATA, THERE IS INSUFFICIENT EVIDENCE TO DETERMINE A DEFINITIVE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING ERRATIC (IMPRECISE) TBHCG RESULTS ABOVE THE NORMAL REFERENCE RANGE THAT DO NOT MATCH THE DIL-HCG RESULTS FOR ONE FEMALE PATIENT FROM THE HOSPITAL'S EMERGENCY DEPARTMENT USING THE LABORATORY'S UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. ALTHOUGH THE TBHCG RESULTS REMAINED ABOVE THE NORMAL REFERENCE RANGE, THEY WERE OUTSIDE THE PRECISION CLAIMS (< 10%) STATED IN THE ASSAY¿S IFU. THE CUSTOMER STATED THAT IT IS LABORATORY PROTOCOL TO RUN A TBHCG AND DIL-HCG TEST ON EACH PATIENT SAMPLE FROM THE EMERGENCY DEPARTMENT FOR WHICH A TBHCG TEST IS ORDERED ON, AND THAT IS HOW THE DISCREPANCY WAS DISCOVERED. ERRATIC (IMPRECISE) TBHCG RESULTS ABOVE THE NORMAL REFERENCE RANGE WERE OBTAINED UPON INITIAL AND REPEAT TESTING AND REPRODUCIBLY ELEVATED DIL-HCG RESULTS ABOVE THE NORMAL REFERENCE WERE OBTAINED ON INITIAL AND REPEAT TESTING. THE PATIENT SAMPLE WAS ALSO SENT TO A SISTER LABORATORY AND ANALYZED ON A SIEMENS CENTAUR ANALYZER WHICH GAVE AN HCG RESULT THAT MATCHED THE DIL-HCG RESULTS OBTAINED ON THE DXI 600 ANALYZER. THE CUSTOMER RELEASED THE INITIAL DIL-HCG RESULT FROM THE LABORATORY AS THE RESULT WAS REPRODUCIBLE AND WAS CONCORDANT WITH AN ALTERNATE METHODOLOGY. THEREFORE, THERE WAS NO CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM CLINICAL CHEMISTRY ANALYZER DHA BECKMAN COULTER INC. DXI 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR