BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1810530 · Received August 20, 2010

    Report

    Report Number
    2122870-2010-00463
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN PLASTIC SERUM TUBES WITH A GEL SEPARATOR. PER CUSTOMER, THE SAMPLES ARE NOT "HELD FOR CLOTTING". THE SAMPLES ARE ONLY ALLOWED TO CLOT IN-BETWEEN THE TIME THE SAMPLE IS DRAWN AND THE TIME THE SAMPLE IS RECEIVED IN THE LAB. QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(6) 2010 PASSED WITHIN INSTRUMENT SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE AND PERFORMED TROUBLESHOOTING AND THEN PERFORMED SYSTEM CHECK AND QC WHICH ALL PASSED WITHIN INSTRUMENT SPECIFICATIONS. ALTHOUGH SAMPLE HANDLING ISSUES MAY HAVE BEEN A CONTRIBUTING FACTOR, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING PRODUCED RESULTS WITHIN THE RISK STRATIFICATION RANGE. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH 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