BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1951814 · Received January 7, 2011

    Report

    Report Number
    2122870-2011-00020
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 8, 2010
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCUTNI SAMPLES WERE COLLECTED IN GLASS LIHEP PLASMA TUBES AND CENTRIFUGED FOR FIVE MINUTES AT 5000 TO 6000 RPM. ACCUTNI QC WAS WITHIN THE CUSTOMER ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. PER THE CUSTOMER SUPPLIED DOCUMENTATION, ROUTINE SYSTEM CHECKS WERE PERFORMED WHICH FAILED. THE CUSTOMER REPLACED THE WASH BUFFER AND RERAN THE SYSTEM CHECK AGAIN WHICH THEN PASSED WITHIN SPECIFICATION. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010 AND ADDRESSED MULTIPLE HARDWARE ISSUES. THE FSE REPLACED THE EXTERNAL WASTE LINE, CLEANED THE MANIFOLD AND FITTINGS, AND REPLACED THE ASPIRATE PROBE PERI-PUMP TUBING. THE FSE PERFORMED A ROUTINE SYSTEM CHECK AND ASSAY QC. NO ISSUES WERE NOTED. ALTHOUGH HARDWARE IS A LIKELY CONTRIBUTING FACTOR, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY ELEVATED ACCUTNI RESULTS ABOVE THE AMI CUT-OFF FOR TWO PATIENTS THAT WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON THE ORIGINAL INSTRUMENT AND AN ALTERNATE INSTRUMENT PRODUCED LOWER RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR BOTH PATIENTS AND AMENDED REPORTS WERE ISSUED. 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 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1