BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT REACTION VESSEL

    MDR report key: 1253524 · Received December 9, 2008

    Report

    Report Number
    1628664-2008-00277
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Report Date
    November 28, 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
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ANALYZER SERIAL NUMBER (B)(4). THE CUSTOMER ISSUE IS NOW ASSOCIATED WITH REMEDIAL ACTION NUMBER 1415939-2/27/09-003-R. AN INVESTIGATION IS IN PROCESS. 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). 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 INVESTIGATION IDENTIFIED RVS 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 INVESTIGATION IDENTIFIED VARIABLES WITHIN THE SUPPLIERS' MOLDING MANUFACTURING PROCESS THAT CONTRIBUTED TO STATIC CHARGE VARIATION ACROSS RV LOTS. OTHER CONTRIBUTING FACTORS THAT CAN GENERATE A STATIC CHARGE ON THE RVS INCLUDE LOW HUMIDITY, HANDLING, SHIPPING AND CREATION OF CHARGE WITHIN THE ARCHITECT INSTRUMENTS THEMSELVES. IN ADDITION, ABBOTT HAS IMPLEMENTED STATIC CHARGE 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 STATES THAT ONE PATIENT SAMPLE GENERATED AN INITIAL ARCHITECT TOTAL BHCG ASSAY RESULT OF 58 MIU/ML (THIS SAMPLE WAS FROM A SECONDARY COLLECTION TUBE). THE CUSTOMER THEN REPEATED THE TEST USING THIS PATIENT'S SAMPLE FROM THE ORIGINAL COLLECTION TUBE AND GENERATED RESULTS OF 6 MIU/ML AND LESS THAN 1.2 MIU/ML. THE CUSTOMER IS REQUESTING A SERVICE CALL. THERE IS NO FURTHER PATIENT INFORMATION AVAILABLE FROM THE CUSTOMER. THERE HAS BEEN NO REPORTED IMPACT TO PATIENT MANAGEMENT AS A RESULT OF THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC TOTAL BHCG LN:7K78| ARCH I2000 LIST NUMBER 8C89-01| ARCH I2000 LIST NUMBER 8C89-01