BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3062309 · Received April 16, 2013

    Report

    Report Number
    2122870-2013-00390
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DECLINED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS TOTAL BETA HUMAN CHORIONIC GONADOTROPHIN (TBHCG) RESULT, ABOVE THE NORMAL REFERENCE RANGE, FOR ONE PATIENT, INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH ACCESS TOTAL BHCG ASSAY AND CALIBRATORS. AN INITIAL RESULT OF APPROXIMATELY 800 IU/L WAS OBTAINED AND RELEASED OUT OF THE LABORATORY. AS A RESULT, THE PHYSICIAN DIAGNOSED ECTOPIC PREGNANCY AND THE PATIENT WAS PREPARED FOR SURGERY. SURGERY WAS CANCELLED WHEN A NEGATIVE REPEAT RESULT WAS OBTAINED. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162390 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other