BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 3971057 · Received July 31, 2014

    Report

    Report Number
    2122870-2014-00552
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PROACTIVELY REPLACED THE ASPIRATE PROBES. THE FSE NOTED THE PIPETTOR WAS OUT OF HORIZONTAL ALIGNMENT AND REALIGNED THE PIPETTOR. THE FSE NOTED AIR BUBBLES IN THE WASH PUMP. THE FSE INSPECTED AND CLEANED THE WASH AND PRECISION VALVES. THE FSE ALSO OBSERVED A LOOSE CONNECTION AT THE WASH BUFFER SUPPLY LINE LEADING IN TO THE WASH MANIFOLD AND TIGHTENED THE TUBING NUT. UPON SYSTEM PRIMING, THE FSE DID NOT NOTE ANY AIR BUBBLES AND COMPLETED A SUCCESSFUL SYSTEM CHECK AND HIGH SENSITIVITY (HS) SYSTEM CHECK. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO SYSTEM HARDWARE. THE WASH BUFFER TUBING LEADING IN TO THE WASH MANIFOLD WAS LOOSE. A DEFINITIVE ROOT CAUSE IS UNKNOWN. (B)(6). THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2014-00551.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULTS, FOR TWO PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THIS REPORT IS TWO OF TWO REFERENCING THE PATIENT ON THE EVENT DATE NOTED. AN INITIAL RESULT OF 0.24 NG/ML WAS OBTAINED BUT WAS NOT RELEASED FROM THE LABORATORY. SUBSEQUENT TESTING OF THE PATIENT'S SAMPLE, ON THE SAME INSTRUMENT, GENERATED A LOWER RESULT OF 0.10 NG/ML. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED SYSTEM ERRORS WERE NOT OBSERVED AT THE TIME OF THE EVENT. THE PATIENT'S SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBE WITHOUT GEL AND CENTRIFUGED IN A STAT-SPIN CENTRIFUGE FOR MORE THAN TEN MINUTES (STANDARD TIME), AT ROOM TEMPERATURE. NO SAMPLE INTEGRITY ISSUES WERE NOTED. THE SAMPLE WAS LESS THAN ONE HOUR AFTER COLLECTION AND STORED AT ROOM TEMPERATURE. THE CUSTOMER INDICATED QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448211 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1