BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2864206 · Received December 10, 2012

    Report

    Report Number
    2122870-2012-01981
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 11, 2012
    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
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTS ACCUTNI SAMPLES IN LITHIUM HEPARIN PLASMA TUBES WHICH ARE CENTRIFUGED FOR FIVE MINUTES IN A STATSPIN CENTRIFUGE (THE CUSTOMER WAS UNABLE TO SUPPLY THE EXACT CENTRIFUGATION SPEED). AFTER CENTRIFUGATION THE SAMPLES ARE ALIQUOTED INTO 0.5ML SAMPLE CUPS FOR ANALYSIS. PER THE CUSTOMER SUPPLIED DATA, QC HAS BEEN PERFORMING WITHIN THE LABORATORY'S ESTABLISHED RANGES FOR THE TIMEFRAME PROVIDED: (B)(6) 2012. IT WAS NOTED THAT ON (B)(6) 2012 THERE WAS ONE FLIER OUT OF RANGE HIGH >3 STANDARD DEVIATION (SD). THE CUSTOMER LAST CALIBRATED THE ACCUTNI ASSAY ON (B)(6) 2012. THE CALIBRATION CURVE PASSED AS ACCEPTED AND HAD SATISFACTORY %CVS OF <2.50%. A ROUTINE SYSTEM CHECK PERFORMED ON (B)(6) 2012 PASSED WITHIN INSTRUMENT SPECIFICATIONS. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE DISCOVERED AN AIR SLUG IN THE WASH PUMP UPON OPENING THE INSTRUMENT. THE FSE ALSO FOUND THAT THE TUBING FOR ASPIRATE PROBE # 2 WAS MISROUTED OVER A WIRING HARNESS WHICH CAUSED RESTRICTION WHEN LOWERING THE PROBES INTO THE REACTION VESSELS (RVS). A SLIGHT KINK IN THE SUBSTRATE PROBE TUBING WAS ALSO NOTED BY THE FSE. THE FSE REPLACED THE SUBSTRATE PROBE ASSEMBLY, ASPIRATE PROBES AND TUBING, REBUILT THE WASH PUMP, AND REPLACED THE WASH PUMP SEAL AND O-RING. MICROBUBBLES WERE STILL OBSERVED DURING PRIMING; THEREFORE THE FSE REPLACED THE WASH ROTOR AND CONFIRMED THE GAP TO THE MOTOR GUIDE. PRIMING OF THE INSTRUMENT DID NOT DEMONSTRATE ANY FURTHER BUBBLES. THE FSE THEN PERFORMED A HIGH SENSITIVITY SYSTEM CHECK, A ROUTINE SYSTEM CHECK AND ASSAY QC; ALL PASSED WITHIN INSTRUMENT AND ASSAY SPECIFICATIONS. IN CONCLUSION, THE WASH ROTOR IS THE CAUSE OF THE EVENT. ADDITIONALLY, THE FSE ADDRESSED OTHER HARDWARE ISSUES INCLUDING MISROUTED TUBING. WHILE THESE OTHER ISSUES MAY HAVE CONTRIBUTED TO THE EVENT IT IS THE REPLACEMENT OF THE WASH ROTOR THAT RESOLVED THE ISSUE OF BUBBLES IN THE WASH PUMP/LINES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO OBTAINING ERRATIC TROPONIN (ACCUTNI) RESULTS FOR ONE (1) PATIENT GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER STATED TO BEC CUSTOMER TECHNICAL SUPPORT (CTS) THAT THE INITIAL RESULT OBTAINED FOR THIS PATIENT WAS 0.24 UG/L. THE LABORATORY'S PROTOCOL IS TO REANALYZE ANY SAMPLE THAT IS >0.15 UG/L. THEREFORE, THE LABORATORY REANALYZED THIS PATIENT'S SAMPLE IN DUPLICATE AFTER RE-CENTRIFUGATION. THE FOLLOWING RESULTS WERE OBTAINED: 1.52 UG/L AND 7.09 UG/L. THE CUSTOMER THEN PERFORMED ASSAY QC WHICH FAILED TO COMPLETE DUE TO A WASH VALVE MOTION ERROR. THE CUSTOMER SENT THE SAMPLE TO ANOTHER "SISTER" LABORATORY THAT USES THE DXI INSTRUMENT. THE SISTER LABORATORY OBTAINED A "NEGATIVE" RESULT. THE CUSTOMER STATED THAT THE 0.24 UG/L RESULT WAS RELEASED FROM THE LABORATORY; HOWEVER, THERE HAS BEEN NO REPORT OF ANY CHANGE TO OR IMPACT TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR