BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2855227 · Received December 3, 2012

    Report

    Report Number
    2122870-2012-01943
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE COLLECTED IN SERUM SEPARATOR TUBES AND CENTRIFUGED FOR 10 MINUTES AT APPROXIMATELY 3,000 RPM. PER CUSTOMER, QC WAS WITHIN THE LABORATORY'S ESTABLISHED LIMITS BEFORE THE EVENT. ALL SYSTEM CHECK PARAMETERS FOR SYSTEM CHECK DATA PROVIDED FROM (B)(4) 2012 WERE PASSING WITHIN SPECIFICATIONS. NO OTHER HYBRITECH PSA, FERRITIN OR ENHANCED CEA RESULTS ARE IN QUESTION AND NO OTHER ASSAYS ARE IN QUESTION. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE AND WAS ABLE TO REPLICATE THE SAMPLE CAROUSEL MOTION ERROR THAT THE CUSTOMER WAS EXPERIENCING. FSE REPLACED THE SAMPLE CAROUSEL HOME AND INDEX OPTICAL SENSORS AND VERIFIED INSTRUMENT AS OPERATING TO PUBLISHED PERFORMANCE SPECIFICATIONS. THE LIKELY CAUSE FOR THIS EVENT IS SAMPLE MISPOSITIONING DUE TO A HARDWARE MALFUNCTION; SPECIFICALLY, AN INTERMITTENT FAILURE OF THE SAMPLE CAROUSEL HOME AND/OR INDEX OPTICAL SENSOR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THREE ERRONEOUS RESULTS (ONE EACH ON HYBRITECH PSA, FERRITIN AND ENHANCED CEA) ON THREE PATIENTS GENERATED BY THEIR ACCESS 2 IMMUNOASSAY SYSTEM. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO AFFECT TO PATIENTS WITH REGARD TO THIS EVENT. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHMENT.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1