BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3081455 · Received April 29, 2013

    Report

    Report Number
    2122870-2013-00366
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLES WERE PLASMA SAMPLES, DRAWN IN 13X75 MM, LITHIUM HEPARIN GREEN-TOP TUBES AND ALIQUOTED INTO INSERT CUPS FOR TESTING. SAMPLES WERE NOT SHORT DRAWS AND DID NOT APPEAR TO HAVE ANY QUALITY ISSUES. SAMPLES ARE CENTRIFUGED FOR 5 MINUTES AT 5000 RPM AT ROOM TEMPERATURE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE OBSERVED INSTRUMENT ISSUES WHEN VISUALLY INSPECTING THE INSTRUMENT WASH AND PRECISION PUMPS. THE FSE NOTED AIR BUBBLES IN THE PUMPS AND ALSO WITHIN THE ASPIRATE PROBE DISPENSE LINES AND THE MAIN PIPETTOR LINE. PER THE FSE, THE WASH PUMP SEALS, THE PRECISION PUMP SEALS, AND THE WASH VALVE SEALS WERE REPLACED. THE FSE ALSO REPLACED THE WASH PUMP ROTOR/STATOR, AND THEN PERFORMED A SYSTEM CHECK WITH PASSING RESULTS. QUALITY CONTROL (QC) RESULTS WERE ALSO PASSING AFTER THE REPAIRS WERE COMPLETE. THE FSE THEN ADVISED THE CUSTOMER TO PERFORM TESTING OF SAMPLES THAT HAD BEEN SENT TO AN OUTSIDE LABORATORY WHILE THE CUSTOMER HAD AWAITED SERVICE AND THE RESULTS THEY OBTAINED WERE MATCHING THE PATIENT RESULTS REPORTED TO THEM BY THE OUTSIDE LABORATORY. THE FSE NOTED THE RESULTS WERE VERY CONSISTENT BETWEEN THE TWO LABORATORIES. HARDWARE IS THE CAUSE OF THIS EVENT. THE ONSITE FSE COMPLETED REPAIRS TO THE INSTRUMENT WASH AND PRECISION PUMPS TO RESOLVE THE ISSUES REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER TO REPORT THEY HAD OBTAINED NON-REPRODUCIBLE, ELEVATED TROPONIN (ACCUTNI) RESULTS FROM THREE PATIENT SAMPLES TESTED ON THEIR ACCESS 2 IMMUNOASSAY SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE RETESTED PER LABORATORY PROTOCOL. THERE WERE NO CHANGES IN PATIENT TREATMENT REPORTED IN CONNECTION TO THIS EVENT. QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE LABORATORY'S ACCEPTABLE RANGE BEFORE AND AFTER THE EVENT. MAINTENANCE AND SYSTEM CHECKS WERE PASSING/UP-TO-DATE. THERE WERE NO ERRORS POSTED IN THE EVENT LOG DURING THE TESTING. THE LABORATORY RETESTED OTHER PATIENT SAMPLES PER LABORATORY PROTOCOL AND NOTED NO ADDITIONAL EVENTS. THIS MDR IS TO REPORT ACCUTNI RESULTS FOR PATIENT ONE (1) AND PATIENT THREE (3). MDR # 2122870-2013-00365 IS SUBMITTED TO REPORT RESULTS FOR PATIENT 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184924 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR