BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2120759 · Received June 10, 2011

    Report

    Report Number
    2122870-2011-01790
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THE SAMPLES WERE PLASMA, COLLECTED ONSITE, AND WERE CENTRIFUGED IN A STAT SPIN EXPRESS 4 FOR 3 MINUTES. THE CUSTOMER RESPUN THE SAMPLES BETWEEN REPEAT TESTING. SYSTEM CHECK REPORTS WERE SUPPLIED FROM (B)(4) 2011. ALL PORTIONS WERE WELL WITHIN THE PUBLISHED SPECIFICATIONS. PRIOR TO THE EVENT QC RESULTS WERE ABOVE THE ESTABLISHED MEAN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011, FOR THIS EVENT. THE FSE FOUND HARD CRUSTED BUILD UP IN THE WASH TOWER NOZZLE, WHICH WAS REMOVED AND CLEANED. THE ULTRASONIC VOLTAGE, TRANSDUCER TEMPERATURE, AND LED TARGET VALUE WERE TOO HIGH AND WERE ADJUSTED BY THE FSE. THE PIPETTOR DISPENSE CHECK SHOWED DROPLETS CLINGING TO THE SIDE OF THE RV. THE FSE ALIGNED THE MAIN PIPETTOR AND THE DISPENSE CHECK IMPROVED. THE FSE PERFORMED PREVENTIVE MAINTENANCE (PM) ON THE SYSTEM WHICH INCLUDED REPLACING THE ASPIRATE AND SUBSTRATE PROBES. THE FSE PERFORMED A SYSTEM CHECK AND ALL PORTIONS PASSED WITHIN PUBLISHED SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING DISCREPANT RESULTS FOR TROPONIN (ACCUTNI) ON TWO (2) PATIENTS' SAMPLES BETWEEN TWO (2) ACCESS 2 IMMUNOASSAY SYSTEMS. THE FIRST SAMPLE RECOVERED ABOVE THE AMI CUTOFF ON ONE SYSTEM AND REPEATED WITHIN THE RISK STRATIFICATION RANGE ON THE OTHER. THE SECOND SAMPLE RECOVERED ABOVE THE AMI CUTOFF AND REPEATED LOWER WITHIN THE SAME CLINICAL RANGE BUT OUTSIDE OF THE STATED INSERT PRECISION CLAIMS. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. THE CUSTOMER STATED THERE WAS NO DEATH OR INJURY TO PATIENT REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR