BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2884584 · Received December 23, 2012

    Report

    Report Number
    2122870-2012-01999
    Event Type
    Malfunction
    Date Received
    December 23, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 27, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN 10 ML BD SERUM SEPARATOR TUBES AND CENTRIFUGED FOR 10 TO 15 MINUTES AT 3,500 RPM. THE CUSTOMER DID NOT REPORT ANY SAMPLE QUALITY ISSUES. THE CUSTOMER RUNS THREE LEVELS OF QC ONCE DAILY ON THE FOLLOWING ASSAYS: HFSH, HLH, PROLACTIN, PSA, FREE PSA, TESTOSTERONE AND PTH. THE CUSTOMER REPORTED ERRATIC QC RECOVERY ON THE DAY OF THE EVENT. SYSTEM CHECKS PERFORMED ON (B)(6) 2012 BOTH PASSED WITHIN SPECIFICATIONS. THE CUSTOMER REPORTED WASH PUMP AND WASH VALVE MOTION ERRORS IN THE EVENT LOG. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED THE WASH VALVE ROTOR AND STATOR. FSE ALSO CLEANED THE WASH WHEEL, REPLACED ALL THREE ASPIRATE PROBES, COMPLETED MIXER PULLEY MODIFICATION AND COMPLETED A 20 REPLICATE PRECISION RUN ON PTH, WHICH PASSED WITHIN SPECIFICATIONS. FSE THEN VERIFIED CUSTOMER'S QC WAS WITHIN THE LABORATORY'S ESTABLISHED LIMITS. INSTRUMENT WAS VERIFIED AS PERFORMING TO PUBLISHED PERFORMANCE SPECIFICATIONS. THE LIKELY CAUSE FOR THIS EVENT IS HARDWARE MALFUNCTION OF THE WASH VALVE. MDR#2122870-2012-02000 DOCUMENTS THE RESULTS GENERATED ON (B)(6) 2012 AT THIS CUSTOMER'S LABORATORY BY THIS INSTRUMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING ERRONEOUS AND/OR IMPRECISE RESULTS ON 16 PATIENT SAMPLES FOR MULTIPLE ASSAYS GENERATED BY THEIR ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THEY RECEIVED WASH PUMP AND WASH VALVE MOTION ERRORS BEGINNING ON (B)(6) 2012. THE CUSTOMER COMPARED THE RESULTS TO PRIOR PATIENT HISTORIES AND INITIALLY QUESTIONED 4 TESTOSTERONE, 40 PSA, 1 FREE PSA, 2 HFSH AND 2 HLH RESULTS. HOWEVER, AFTER REPEATING THE SAMPLES ON (B)(6) 2012 (AFTER THE INSTRUMENT WAS SERVICED) THE CUSTOMER AMENDED REPORTS FOR A TOTAL OF 16 PATIENT SAMPLES (13 PSA, 1 HLH AND 2 TESTOSTERONE). THE CUSTOMER STATED THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY, BUT THE CUSTOMER WAS ABLE TO ALERT PHYSICIANS TO THE ERRONEOUS RESULTS BEFORE CHANGE TO PATIENT TREATMENT OCCURRED. THE CUSTOMER DID NOT REPORT AFFECT TO PATIENTS OR USERS ATTRIBUTED OR CONNECTED TO THIS EVENT. THIS REPORT DOCUMENTS THE RESULTS GENERATED ON (B)(6) 2012. A SEPARATE REPORT HAS BEEN SUBMITTED TO DOCUMENT THE ERRONEOUS RESULTS GENERATED ON (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1