BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2083827 · Received May 10, 2011

    Report

    Report Number
    2122870-2011-01350
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: FROM DATE: 04/07/2011, PATIENT/SAMPLE: 1/1, INITIAL RUN RESULT: 10.83 , >98.00 , >98.00, REPEAT RUN RESULTS: 0.00. TO DATE: 04/11/2011, PATIENT/SAMPLE RESULT: 1/1, INITIAL RUN RESULT: 10.83 , >98.00 , >98.00, REPEAT RUN RESULTS: 0.00.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    SAMPLE AND CENTRIFUGATION INFORMATION WAS NOT PROVIDED. ON (B)(4) 2011 SYSTEM CHECK WAS PERFORMED WHICH PASSED WITHIN SPECIFICATIONS. ON (B)(4) 2011, ACCUTNI CALIBRATION WAS PERFORMED WHICH PASSED WITHIN SPECIFICATIONS. PER CUSTOMER, THE SYSTEM WAS DISPLAYING WASH VALVE/PUMP MOTION ERRORS. A BCI FIELD SERVICE ENGINEER (FSE) FOUND THE BUFFER LINE CRIMPED BETWEEN THE ACCESS AND FLUIDICS TRAY. FSE REPLACED THE BUFFER CLAMP, THE ORIGINAL CLAMP WAS MISSING. FSE PERFORMED VERIFICATION TESTING WHICH PASSED WITHIN SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH ACCUTNI RESULT ABOVE THE ACUTE MYOCARDIAL INFRACTION (AMI) CUT OFF FOR THREE PATIENTS GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED ON AN ALTERNATE UNIT AND LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE WERE OBTAINED. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALSO REPORTED DISCREPANT THYROID-STIMULATING HORMONE (TSH) RESULTS FOR ONE PATIENT. THE DISCREPANT TSH RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THERE HAS BEEN NO REPORT OF PATIENT DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER, MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1