BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3073684 · Received April 23, 2013

    Report

    Report Number
    2122870-2013-00361
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    CDD
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC REVIEW SHOWED THAT IN BETWEEN THE LOW RESULTS AND THE NORMAL RESULTS THE CUSTOMER OBTAINED NO VALUE NCR (NO CALIBRATION CURVE) RESULTS. BASED ON THE DATA PROVIDED, IT APPEARED THAT THIS WAS DUE TO OBTAINING A FAILING CALIBRATION CURVE WHICH THE PATIENT SAMPLES WERE ANALYZED ON. THE SAMPLES WERE COLLECTED IN 7ML BECTON DICKINSON (BD) SERUM TUBES AND CENTRIFUGED FOR 10 MINUTES AT 3000 RPM IN A SWINGING BUCKET CENTRIFUGE. THERE WERE NO ISSUES NOTED WITH SAMPLE COLLECTION, SAMPLE PROCESSING OR SAMPLE HANDLING IN CONJUNCTION WITH THIS EVENT. ALL OF THE SYSTEM PARAMETERS, INCLUDING QC AND SYSTEM CHECK, WERE PERFORMING WITHIN THE ASSAY AND INSTRUMENT SPECIFICATIONS PRIOR TO THE EVENT. IMMEDIATELY FOLLOWING THE EVENT THAT CUSTOMER REANALYZED THE VITAMIN B12 QC AND NOTED THAT IT FAILED OUT OF RANGE LOW. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE AND WAS ABLE TO REPLICATE THE CUSTOMER'S ISSUE BY PERFORMING A 50 REPLICATE PRECISION TEST. THE FSE REPLACED THE TRANSDUCER AND THE ULTRASONIC PCB BOARD BUT THE ISSUE WAS NOT RESOLVED. THE FSE RETURNED ON-SITE THE FOLLOWING DAY AND REPLACED BOTH THE Z-SERVICE LOOP AND THE X-SERVICE LOOP CABLES AND INSTALLED A NEW ULTRASONIC PCB BOARD AND PERFORMED THE NECESSARY ALIGNMENTS AND ADJUSTMENTS. ALL VERIFICATION TESTING PERFORMED AFTER THE REPAIRS WERE COMPLETED PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE CAUSE OF THIS EVENT IS ATTRIBUTED TO THE ULTRASONIC SERVICE LOOP CABLES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT DISCREPANT LOW VITAMIN B12 RESULTS FOR SEVEN PATIENTS GENERATED BY AN ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING OF THE SAMPLES ON A NEW VITAMIN B12 REAGENT PACK (ACCESS VITAMIN B12 LOT NUMBER 225396) PRODUCED HIGHER RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR SIX OF THE PATIENTS AND A HIGHER RESULT STILL BELOW THE NORMAL REFERENCE RANGE FOR THE SEVENTH PATIENT. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHMENT. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO INJURY OR AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173353 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER CDD BECKMAN COULTER ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1