BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT REACTION VESSEL

    MDR report key: 1575281 · Received January 12, 2010

    Report

    Report Number
    1415939-2010-00157
    Event Type
    Malfunction
    Date Received
    January 12, 2010
    Date of Event
    March 13, 2009
    Report Date
    March 13, 2009
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO METHOD, RESULTS OR CONCLUSIONS CAN BE MADE AT THIS TIME. 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). 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

    POST STENT DILATION, THERE WAS A PERIOD OF HYPOTENSION AND BRADYCARDIA. THE PATIENT AT THE TIME WAS GROGGY AND HAD RIGHT UPPER EXTREMITY WEAKNESS. THE PATIENT WAS SUBSEQUENTLY TREATED WITH IV NEOSYNEPHRINE AND ATROPINE. THERE WAS IMPROVEMENT OF THE SYMPTOMS. IT WAS ALSO NOTED THAT THE DAY OF THE INDEX PROCEDURE THE PATIENT EXPERIENCED RIGHT HEMIPARESIS AND WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK WITH NEUROLOGICAL DEFICITS LASTING LESS THAN 24 HOURS AND WITH FULL RECOVERY. THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY ON (B)(6) 2010 WITH A LESION IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. THE LESION HAD 90% STENOSIS AND WAS ECCENTRIC, MILDLY CALCIFIED AND 15MM IN LENGTH. THE VESSEL WAS 5.5MM IN DIAMETER AND MILDLY TORTUOUS. AN ANGIOGUARD WAS PLACED AND A PRECISE STENT WAS SUCCESSFULLY IMPLANTED. THE FINAL PERCENTAGE OF STENOSIS WAS 10%. THE PATIENT WAS DISCHARGED TWO DAYS LATER ON ASPIRIN AND CLOPIDOGREL.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000 ANALYZER USING REACTION VESSELS OF LOT 71234P100 GENERATED ERROR CODE 1007, UNABLE TO PROCESS TEST, ACTIVATED READ ERROR. THE ERROR WAS RESOLVED BY REPLACING THE REACTION VESSELS WITH THOSE OF A DIFFERENT LOT. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT 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 71234P100

    Patients

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