BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT REACTION VESSEL

    MDR report key: 1211983 · Received October 28, 2008

    Report

    Report Number
    1628664-2008-00246
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Report Date
    October 3, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Removal / Correction Number
    1415939-2/27/09-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS NOW ASSOCIATED WITH THE REMEDIAL ACTION NUMBER 1415939-2/27/09-003-R. THE INITIAL MDR WAS FILED AGAINST THE ARCHITECT I2000 ANALYZER, LIST NUMBER 8C89-01, MANUFACTURING SITE,(B)(4). UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE CAUSATIVE AGENT FOR THIS ISSUE IS THE ARCHITECT REACTION VESSELS;. AN INVESTIGATION IS STILL IN PROGRESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED, WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE INVESTIGATION UNIT HAS EVALUATED THIS CUSTOMER COMPLAINT AND HAS DETERMINED THAT IT IS NOT ASSOCIATED WITH REMEDIAL ACTION REPORTING NUMBER 1415939-2/27/09-003-R AND IS THEREFORE UNASSIGNED. AN INVESTIGATION OF THIS COMPLAINT IS IN PROCESS. AN INCORRECT CORRECTION AND REMOVAL REPORTING NUMBER WAS DOCUMENTED ON THE PREVIOUS MEDWATCH FORM FOR THIS COMPLAINT. THE CORRECTED NUMBER IS NO LONGER REQUIRED AS THIS COMPLAINT WAS UNASSIGNED FROM THAT ACTION. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER REVIEW, THE CUSTOMER ISSUE IS NOW ASSOCIATED WITH (B)(4) ACTION REPORTING NUMBER (B)(4), AS THE LOT OF THE SUSPECT REACTION VESSEL WAS IN USE AT THE CUSTOMER FACILITY. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION DETERMINED THE CAUSES OF THE INCREASE IN FREQUENCY OF STATIC DISCHARGE EVENTS WERE DUE TO THE ARCHITECT REACTION VESSELS (RVS) SUPPLIER'S MANUFACTURING MATERIAL AND MANUFACTURING PROCESSES. THE PREVIOUS INVESTIGATION IDENTIFIED RV LOTS MADE FROM A PARTICULAR POLYPROPYLENE RESIN LOT WERE RESPONSIBLE FOR A MAJORITY OF THE STATIC DISCHARGE EVENTS. ANALYSIS OF THIS RESIN LOT DETERMINED IT HAS UNIQUE COMPOSITIONAL AND ANALYTICAL CHARACTERISTICS WHEN COMPARED TO OTHER RESIN LOTS, WHICH FACILITATED THE BUILD-UP OF STATIC CHARGE ON THE RVS. THE PREVIOUS INVESTIGATION ALSO IDENTIFIED VARIABLES WITHIN THE SUPPLIERS' MOLDING MANUFACTURING PROCESS THAT CONTRIBUTED TO STATIC CHARGE VARIATION ACROSS RV LOTS. THE LATEST INVESTIGATION IDENTIFIED ADDITIONAL VARIABLES WITHIN THE SUPPLIERS MOLDING MANUFACTURING PROCESS. ABBOTT HAS IMPLEMENTED MORE STRINGENT STATIC CHARGE SAMPLING AND TESTING FOR ACCEPTANCE OF ALL INCOMING RV LOTS FROM OUR SUPPLIER. ABBOTT HAS WORKED IN CLOSE COLLABORATION WITH OUR SUPPLIERS TO ASSURE CONSISTENCY OF INCOMING RESIN MATERIAL, AND TO IMPROVE THE SUPPLIER'S MOLDING PROCESS TO REDUCE THE POTENTIAL GENERATION OF STATIC CHARGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED CA 19-9 RESULTS ARE NOT REPRODUCIBLE ON THE ARCHITECT ANALYZER. A PATIENT GENERATED AN INITIAL RESULT OF 28 U/ML. THE SAMPLE WAS RETESTED ON ANOTHER ARCHITECT ANALYZER WITH A RESULT OF 18 U/ML. WHEN THE SAMPLE WAS RETESTED ON THE ORIGINAL ANALYZER, THE RESULT WAS 42.8 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT REACTION VESSEL REACTION VESSELS FOR CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAYS JJE ABBOTT LABORATORIES 65386P100

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000, LN 8C89-01, (B)(4)| ARCHITECT I2000, LN 8C89-01, (B)(4)| ARCHITECT I2000, LN 8C89-01, (B)(4)| ARCHITECT I2000, LN 8C89-01, (B)(4)