BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 3831198 · Received May 23, 2014

    Report

    Report Number
    2122870-2014-00349
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE DETERMINED THE REAGENT CAROUSEL MOTION ERROR WAS CAUSED BY AN IMPROPERLY SEATED THERMISTOR, WHICH WAS RUBBING AGAINST THE BOTTOM OF THE CAROUSEL. THE FSE RESEATED THE THERMISTOR. THE FSE ALSO PROACTIVELY REPLACED THE FOLLOWING COMPONENTS: PIPETTOR PROBE AND PERI-PUMP TUBING, SEALS AND O-RINGS. THE FSE SUCCESSFULLY PERFORMED PIPETTOR ALIGNMENTS AND ULTRASONIC ADJUSTMENTS, BUT OBTAINED LEVEL SENSE ERRORS DURING A PRECISION RUN. THE FSE REPLACED THE ULTRASONIC TRANSDUCER AND CIRCUIT BOARD. ASSOCIATED MDR: 2122870-2014-00348. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DISCREPANT RESULTS WERE OBTAINED FOR EIGHT PATIENTS OVER TWO DAYS ON AN ACCESS 2 IMMUNOASSAY SYSTEM. THIS REPORT REFERENCES THE EVENT THAT OCCURRED ON (B)(6) 2014; PLEASE REFER TO MDR 2122870-2014-00348 FOR THE EVENT THAT OCCURRED ON (B)(6) 2015. ON (B)(6) 2014, DISCREPANT RESULTS FOR FERRITIN, T-UPTAKE, AND/OR VITAMIN B12 WERE OBTAINED FOR SEVEN PATIENTS AND REPORTED OUT OF THE LABORATORY. THE RESULTS WERE QUESTIONED BY THE CLINICIAN AND THERE WAS NO CHANGE TO PATIENT TREATMENT. THE PATIENT SAMPLES WERE RERUN ON THE SAME INSTRUMENT AND RESULTS WERE WITHIN EXPECTED VALUES. THE INITIAL RESULTS WERE CORRECTED. THE INSTRUMENT PASSED SYSTEM CHECK BEFORE THE EVENT AND PASSED TWICE AFTER THE EVENT. THE CUSTOMER'S SERVICE RECORD NOTES REAGENT CAROUSEL MOTION ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308227 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1