BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2083705 · Received May 10, 2011

    Report

    Report Number
    2122870-2011-01356
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WERE NOT SUPPLIED. SYSTEM CHECK DATA WAS NOT SUPPLIED. INSTRUMENT WAS REPORTING "WASH VALVE MOTION ERRORS" AT TIME OF EVENT. BCI FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT. FSE HAD BEEN ON SITE ON (B)(4) 2011 TO ADDRESS THE WASH VALVE MOTION ERRORS AND REPLACED THE WASH PUMP ASSEMBLY AT THAT TIME. ALTHOUGH HARDWARE MAY BE A CONTRIBUTING FACTOR, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    WHEN CONTACTED BY BECKMAN COULTER INC. (BCI) REGARDING THE TROPONIN (ACCUTNI) ASSAY PERFORMANCE, THE CUSTOMER STATED THAT THEIR LABORATORY HAD OBTAINED FALSE POSITIVE TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE, GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER, FOR ONE (1) PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB. THE SAMPLE WAS RE-TESTED AND GENERATED LOWER RESULTS. THE PATIENT REPORT WAS AMENDED WITH THESE RESULTS. THE CUSTOMER REPORTED THAT THERE WAS NO INSTANCE OF DEATH, INJURY, SERIOUS MEDICAL DETERIORATION, OR INAPPROPRIATE MEDICAL TREATMENT DUE TO EVENT.

    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