BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2001976 · Received February 27, 2011

    Report

    Report Number
    2122870-2011-00498
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAS NOT BEEN SUPPLIED TO DATE. QC AND SYSTEM INFORMATION HAS NOT BEEN SUPPLIED TO DATE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE PERFORMED A SUBSTRATE VOLUME CHECK, WHICH FAILED. THE FSE THEN REPLACED THE SUBSTRATE PUMP AND DECONTAMINATED THE SUBSTRATE SYSTEM. THE FSE ALSO RECALIBRATED ALL ASSAYS AND PERFORMED QC; NO ISSUES WERE NOTED. HARDWARE IS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING A LOWER THAN EXPECTED TROPONIN (ACCUTNI) RESULT WITHIN THE NORMAL REFERENCE RANGE FOR ONE PATIENT GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY; HOWEVER, SUBSEQUENT TESTING PRODUCED A HIGHER RESULT ABOVE THE AMI CUT-OFF. THE AFFECT, IF ANY, TO THE PATIENT IS UNKNOWN AT THIS TIME FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1