BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 3951471 · Received July 22, 2014

    Report

    Report Number
    2122870-2014-00531
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION:THE FIELD SERVICE ENGINEER (FSE) NOTED A BENT MAIN PIPETTOR TIP AND REPLACED THE PIPETTOR TIP. THE FSE SET THE TRANSDUCER VOLTAGE AND ADJUSTED THE MIXER SPEED TO RESOLVE THE REPORTED ISSUE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION.(B)(4)

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) NOTED A BENT MAIN PIPETTOR TIP AND REPLACED THE PIPETTOR TIP. THE FSE SET THE TRANSDUCER VOLTAGE AND ADJUSTED THE MIXER SPEED TO RESOLVE THE REPORTED ISSUE. THE FSE NOTED THE VACUUM READING LOW AND REPLACED THE VACUUM PUMP. A LOW VACUUM WOULD RESULT IN A SYSTEM FLAG MESSAGE VACUUM UNDER LIMITS ERRORS, AND ALL RESULTS WOULD BE SUPPRESSED. THERE IS NO POTENTIAL FOR ERRONEOUS RESULTS TO BE GENERATED WITH THIS SYSTEM ERROR. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE BENT MAIN PIPETTOR TIP. A DEFINITIVE ROOT CAUSE IS UNKNOWN. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2014-00530.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI) RESULTS, ABOVE THE NORMAL REFERENCE RANGE, 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 0.206 NG/ML WAS OBTAINED BUT WAS NOT RELEASED FROM THE LABORATORY. THE CUSTOMER INDICATED THE SAMPLE WAS IMMEDIATELY RETESTED ON THE SAME INSTRUMENT, IN DUPLICATE, WITH RESULTS OF 0.022 AND 0.022 NG/ML. THE CUSTOMER STATED THE RESULT OF 0.022 NG/ML WAS REPORTED TO THE HOSPITAL. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED THE LABORATORY RETESTS ALL PATIENT SAMPLES WITH TROPONIN I RESULTS ABOVE 0.10 NG/ML. THE PATIENTS' SAMPLES WERE COLLECTED IN 12X100 MM BECTON DICKINSON (BD) SERUM SEPARATOR TUBES (SST) AND CENTRIFUGED FOR FIVE MINUTES. QUALITY CONTROL (QC) RECOVERED WITHIN THE LABORATORY'S ACCEPTABLE RANGE PRIOR TO AND AFTER THE EVENT. SYSTEM CHECK WAS ALSO WITHIN SPECIFICATION. THERE WERE NO SYSTEM ERRORS NOTED, IN THE EVENT LOG, DURING TESTING. SERVICE WAS REQUESTED AND A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428514 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR