BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 4632411 · Received March 25, 2015

    Report

    Report Number
    2122870-2015-00176
    Event Type
    Malfunction
    Date Received
    March 25, 2015
    Date of Event
    February 28, 2015
    Report Date
    March 1, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE ANY PATIENT DEMOGRAPHICS INFORMATION (AGE, DATE OF BIRTH, GENDER, AND WEIGHT). A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2015 TO EVALUATE THE ACCESS 2 IMMUNOASSAY SYSTEM. DURING THE SYSTEM PRIMING, THE FSE NOTED THE PRESENCE OF MICRO BUBBLES WITHIN THE WASH PUMP ASSEMBLY. THE FSE ASSESSMENT INCLUDED THAT THE CAUSE OF MICRO BUBBLES IN THE WASH PUMP WAS DUE TO THE WASH VALVE MOTOR. THE FSE REPLACED THE WASH VALVE MOTOR, RAN REPLICATES OF DISPENSE/ PIPETTOR FUNCTIONS AND NO MORE MICRO BUBBLES WERE OBSERVED. THE FSE PERFORMED SYSTEM VALIDATION AND VERIFICATION TESTS PER ESTABLISHED PROCEDURES WHICH MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE, FALSELY ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR FIVE SAMPLES FROM TWO PATIENTS INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). THE CUSTOMER STATED THAT THE INITIAL ELEVATED RESULTS WERE RELEASED FROM THE LABORATORY, AND QUESTIONED BY THE PHYSICIAN. THE FOLLOWING DAY, THE CUSTOMER REANALYZED THE PATIENTS' SAMPLES ON THE SAME ACCESS 2 IMMUNOASSAY SYSTEM AND OBTAINED LOWER RESULTS. THE CUSTOMER ISSUED CORRECTIVE REPORTS. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. QUALITY CONTROLS (QC), CALIBRATIONS AND SYSTEM CHECK PARAMETERS WERE RECOVERING WITHIN ASSAY/INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. TWO 10-POINT PRECISION STUDIES USING THE ACCESS ACCUTNI+3 REAGENTS ON BOARD PASSED WITHIN PUBLISHED SPECIFICATIONS. THE PATIENTS' SAMPLES ARE COLLECTED IN 13 MM X 100 MM LITHIUM HEPARIN TUBES AND CENTRIFUGED IN A STATSPIN CENTRIFUGE AT UNKNOWN RPMS (REVOLUTIONS PER MINUTE) FOR FIVE (5) MINUTES. NO SAMPLE INTEGRITY ISSUES WERE NOTED BY THE CUSTOMER. REPEAT ANALYSIS OF THE PATIENTS' SAMPLES WAS PERFORMED ON REFRIGERATED STORED SAMPLES BETWEEN THE INITIAL AND REPEAT RUNS. SERVICE WAS REQUESTED AND A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE ACCESS 2 IMMUNOASSAY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200609 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1