BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3130914 · Received May 24, 2013

    Report

    Report Number
    2122870-2013-00485
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED DISPENSE PROBE #2 WAS NOT PROPERLY SEATED, WHICH LED TO IMPROPER DISPENSING OF WASH BUFFER AND INCOMPLETE WASHING WITHIN THE REACTION VESSELS (RVS). THE FSE PROPERLY SEATED DISPENSE PROBE #2 AND PERFORMED SYSTEM VERIFICATION TESTING. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. THE CUSTOMER STATED WEEKLY SYSTEM MAINTENANCE WAS PERFORMED ON THE INSTRUMENT ON THE MORNING OF THE EVENT AND IMPROPERLY SEATING DISPENSE PROBE #2 WAS LIKELY. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2013-00484.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION, FOR SEVERAL PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM UTILIZED IN CONJUNCTION WITH THE ACCESS ACCUTNI REAGENT AND CALIBRATOR. SUBSEQUENT ANALYSIS OF THE PATIENTS¿ SAMPLES, ON AN ALTERNATE ACCESS 2 INSTRUMENT, RECOVERED LOWER TROPONIN I RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS PATIENT RESULTS WERE RELEASED OUT OF THE LABORATORY. AS A RESULT, TWO PATIENTS WERE ADMITTED TO THE HOSPITAL BASED ON THE FALSE VALUES. IT IS UNKNOWN IF ANY ADDITIONAL TREATMENT WAS GIVEN TO THE PATIENTS. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. QUALITY CONTROL (QC) WAS WITHIN RANGE ON THE MORNING OF THE EVENT. THE CUSTOMER REPEATED QUALITY CONTROL (QC), AND QC WAS HIGH FOR ALL THREE LEVELS. QC WAS REPEATED AGAIN AND WAS ELEVATED FOR ALL THREE LEVELS. THE CUSTOMER ATTEMPTED TO CALIBRATE BUT CALIBRATION FAILED FOR BAD FIT. THE CUSTOMER SENT FOUR SAMPLES TO A REFERENCE LABORATORY FOR SAMPLE REANALYSIS; THE RESULTS ARE UNKNOWN. THE PATIENT SAMPLES WERE COLLECTED IN THE EMERGENCY ROOM (ER) INTO 4.5 ML BECTON DICKINSON (BD) TUBES AND CENTRIFUGED AT 5,600 RPM (ROTATIONS PER MINUTE) FOR FIVE MINUTES, AT ROOM TEMPERATURE. THE SAMPLES WERE NORMAL IN APPEARANCE. AN ALIQUOT WAS PIPETTED FROM THE SAMPLE INTO AN INSERT CUP AND TESTING WAS PERFORMED FROM THE INSERT CUP. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THIS REPORT REFERENCES THE SECOND PATIENT THAT WAS ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231437 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization