BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1100164 · Received July 30, 2008

    Report

    Report Number
    2122870-2008-00233
    Event Type
    Other
    Date Received
    July 30, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 30, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN PLASTIC BD LITHIUM HEPARIN TUBES WITH GEL AND SPUN IN A SWINGING BUCKET CENTRIFUGE. AFTER THE FIRST EVENT, ALL ASSAY TESTING WAS BEING PERFORMED IN DUPLICATE UNTIL THE FSE COULD ARRIVE. THESE WERE THE ONLY SAMPLES IN QUESTION. SYSTEM CHECK WAS PERFORMED IN 2008 AND ALL PORTIONS WERE WITHIN PUBLISHED SPECIFICATIONS. CUSTOMER INDICATED THEY RUN QC EVERY 8 HOURS AND WAS RECOVERING WITHIN RANGE BEFORE AND AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS ONSITE SIX DAYS LATER AND THE FOLLOWING DAY: FSE STATED HE FOUND TWO ASPIRATE PROBES THAT WERE BENT AND THE SUBSTRATE DELIVERY PROBE WAS DAMAGED. FSE PERFORMED A SUBSTRATE DELIVERY TEST WHICH DEMONSTRATED THAT SUBSTRATE WAS NOT BEING DISPENSED CORRECTLY. FSE ALSO NOTED THAT THE SUBSTRATE BACKLASH WAS NOT ADEQUATELY BEING DRAWN BACK IN THE SUBSTRATE PUMP AND REPLACED THE SUBSTRATE PUMP. FSE PERFORMED A PREVENTIVE MAINTENANCE (PM) THAT WAS DUE. FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES MAY HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUS ACCUTNI RESULTS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS. CUSTOMER TESTED A PATIENT SAMPLE FOR ACCUTNI AND OBTAINED A RESULT OF 0.21NG/ML WHICH REPEATED AT 0.01 NG/ML. ANOTHER PATIENT SAMPLE WHEN TESTED GAVE A RESULT OF 0.09NG/ML AND A REPEAT RESULT OF 0.01NG/ML. A THIRD PT SAMPLE GAVE AN ACCUTNI RESULT OF 0.03NG/ML WHICH REPEATED AT 0.12 AND 0.13 NG/ML. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIANS. 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA