BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2262820 · Received September 24, 2011

    Report

    Report Number
    2122870-2011-04102
    Event Type
    Malfunction
    Date Received
    September 24, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTS PSA SAMPLES IN BECKTON DICKINSON SERUM SEPARATOR TUBES. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE. THE PATIENT SAMPLE WAS SENT TO BEC CPLS (CUSTOMER PRODUCT LINE SUPPORT) FOR FURTHER TESTING AND CPLS CONFIRMED THE PRESENCE OF A HETEROPHILE INTERFERENCE WHICH IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING A HIGHER THAN EXPECTED FREE PROSTATE SPECIFIC ANTIGEN (PSA) RESULT GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM THAT DID NOT MATCH THE HYBRITECH PSA RESULT FOR ONE PATIENT. SUBSEQUENT TESTING ON ANOTHER SPECIMEN FROM THE SAME PATIENT RESULTED SIMILARLY WITH A HIGHER THAN EXPECTED FREE PSA RESULT THAT DID NOT MATCH THE HYBRITECH PSA RESULT. ADDITIONAL TESTING DONE BY THE CUSTOMER USING A HETEROPHILE BLOCKING TUBE (HBT) PRODUCED A FREE PSA RESULT THAT BETTER MATCHED THE HYBRITECH PSA RESULT. 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® DXL 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1