BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2704996 · Received August 17, 2012

    Report

    Report Number
    2122870-2012-01683
    Event Type
    Malfunction
    Date Received
    August 17, 2012
    Date of Event
    July 23, 2012
    Report Date
    July 23, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: CUSTOMER DID NOT REQUEST SERVICE FROM BEC. THE QUALITY CONTROL DATA INDICATES QUALITY CONTROL RECOVERED WITHIN THE LABORATORY ESTABLISHED RANGES. CAUSE IS UNKNOWN. REAGENTS USED IN CONJUNCTION WITH UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER: CATALOG NO.: 33505, BRAND NAME: ACCESS TOTAL B-HCG I CALIBRATORS, LOT NUMBER: 113070. CATALOG NO.: 33500, BRAND NAME: ACCESS TOTAL B-HCG, 2 X 50 TESTS, LOT NUMBER: 119436.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (DXI 800) GENERATED ELEVATED BHCG PATIENT RESULTS ON THREE PLASMA SAMPLES OBTAINED FROM ONE PATIENT. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS FROM THE PLASMA SAMPLES WERE REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT THE PHYSICIAN QUESTIONED THE RESULTS. CUSTOMER REPORTED THAT THEY COLLECTED A SERUM SAMPLE AND RAN THE SERUM SAMPLE ON THE ACCESS 2 INSTRUMENT IN THE REFERENCE LABORATORY WHICH RECOVERED A NORMAL RESULT. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1