BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 1030606 · Received April 16, 2008

    Report

    Report Number
    1628664-2008-00091
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABBOTT FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO INSPECT THE INSTRUMENT. THE R1 AND R2 SYRINGES WERE REBUILT, CONTROLS WERE RUN WITHOUT ISSUE. A 20-CUP PRECISION TEST WAS RUN WITH RESULTS WITHIN SPECIFICATIONS. ALSO, THE PVT (PERFORMANCE VERIFICATION TEST) WAS PERFORMED WITH ACCEPTABLE RESULTS. A DIFFERENCE IN RESULTS WAS OBSERVED BETWEEN SAMPLE CUPS AND SAMPLE TUBES. THE LABORATORY WATER SUPPLY WAS INSPECTED AND FOUND TO BE ACCEPTABLE. THE CARBON TANK, FILTER, AND UV LAMP WERE REPLACED. THE FIELD SERVICE REPRESENTATIVE CONFIGURED THE RETEST RULES FOR ALL CALCIUM RESULTS GREATER THAN 10.5 MG/DL. THE MIXERS WERE INSPECTED AND NO CHIPS OR CRACKS WERE OBSERVED. THE TEXT INDICATES THE SAMPLE PROBE HAD BEEN AN ISSUE WITH GEL ON THE PROBE AND CALIBRATION ISSUES. THE FIELD SERVICE REPRESENTATIVE CHECKED LIQUID LEVEL SENSE (LLS) VOLTAGES AND REPLACED THE LLS AND PRESSURE MONITORING BOARDS. THE CUSTOMER WAS UNAWARE OF THE MINIMUM SAMPLE REQUIREMENT LABEL ON THE ARCHITECT CARRIERS AND WAS UNABLE TO VERIFY IF ADEQUATE SAMPLE VOLUME ABOVE THE GEL BARRIER HAD BEEN PRESENT. REVIEW OF THE CENTRIFUGE TIMES REVEALED FOUR DIFFERENT CENTRIFUGES WERE USED, EACH WITH A DIFFERENT SPIN TIME FROM 5 MINUTES TO 10 MINUTES. THE CUSTOMER SUPPORT SPECIALIST REVIEWED WITH THE CUSTOMER THE RECOMMENDATIONS FROM GREINER BIO-ONE VACUETTES FOR SAMPLE PROCESSING PER PRODUCT INSERTS FROM THEIR WEBSITE. THE MANUFACTURER RECOMMENDS CENTRIFUGATION FOR 15 MINUTES AT 2000-3000G. THE CUSTOMER IS USING PLASTIC TUBES, GREINER BIO-ONE, 5 ML LITHIUM HEPARIN TUBES AND 6 ML SODIUM HEPARIN TUBES. THE CUSTOMER STATES THAT THE OPERATORS HAD COMMENTED ON THE OCCURRENCE OF FIBRIN IN PATIENT SAMPLES AND STATED THAT FREQUENT ASPIRATION ERRORS OCCUR, DUE TO FIBRIN IN THE SAMPLES. A REVIEW OF THE CUSTOMER'S SAMPLE HANDING PROCEDURES FOUND THAT SAMPLES COLLECTED BY THE PHLEBOTOMISTS ARE NOT FROM PATIENT'S HEPARIN LOCKS. THE CUSTOMER INDICATED THAT NONE OF THE SAMPLES WITH DISCREPANT RESULTS WERE RECENTRIFUGED AND TESTED. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. END OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ERRATIC PATIENT RESULTS ARE BEING GENERATED BY THE ARCHITECT C8000 CALCIUM ASSAY. THE CUSTOMER GAVE ONE EXAMPLE OF AN INITIAL RESULT OF 11.9 MG/DL THAT RETESTED AT 9.3 AND 17.7 MG/DL. THE CUSTOMER ALSO MENTIONED THAT A NURSE COMMENTED THAT OVER THE PAST WEEK PATIENT CALCIUM RESULTS SEEMED A LITTLE ELEVATED. UPON TROUBLESHOOTING, IT WAS DISCOVERED THAT THE CUSTOMER IS TOPPING OFF BOTH ACID AND ALKALINE WASH SOLUTIONS, SOMETIMES WHEN THE BOTTLE IS ONLY HALF FULL. THE CUSTOMER STATES THAT THEY DO THIS SO THAT THEY DO NOT HAVE TO STOP IN THE MIDDLE OF THE DAY TO REPLACE REAGENTS AND SUPPLIES. THE CTA ADVISED THE CUSTOMER TO REMOVE AND REPLACE THE WASH SOLUTIONS WITH NEW CONTAINERS AND SOLUTIONS ON BOTH ANALYZERS IN THE LAB AND TO DISCONTINUE THE PRACTICE OF TOPPING OFF SOLUTIONS. THE CUSTOMER AGREED. ALSO, THE CUSTOMER MENTIONED THAT THEY OFTEN HAVE ISSUES WITH FIBRIN IN THE PATIENT SAMPLES TO BE TESTED. THE CTA AND THE CUSTOMER REVIEWED THE CUSTOMER'S SAMPLE COLLECTION AND HANDLING PROCEDURES. A SERVICE CALL WAS ALSO INITIATED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI CLINICAL CHEMISTRY CALCIUM ASSAY LIST# 7D61-20| LOT#: 59050HW00