BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 1543135 · Received November 23, 2009

    Report

    Report Number
    1628664-2009-00614
    Event Type
    Malfunction
    Date Received
    November 23, 2009
    Date of Event
    August 24, 2009
    Report Date
    October 25, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Removal / Correction Number
    1628664-7/24/09-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: UNDER CERTAIN CONDITIONS, SODIUM AZIDE CAN REACT WITH UNPROTECTED COPPER TO FORM CORROSION WHICH CAN FURTHER DEVELOP INTO AN EXPLOSIVE COMPOUND; THE COPPER PRESENT IN THE GROUND STRAP WAS EXPOSED TO SODIUM AZIDE FOR A LONG ENOUGH PERIOD OF TIME TO FORM CORROSION. AN INVESTIGATION WAS CONDUCTED AND CONCLUDED THAT UNDER CERTAIN CONDITIONS, SODIUM AZIDE CAN REACT WITH UNPROTECTED COPPER TO FORM AN EXPLOSIVE COMPOUND. INDEPENDENT STUDIES WERE PERFORMED TO DETERMINE THE CHEMICAL COMPOSITION OF DEPOSITS FOUND ON FIELD RETURNED GROUND STRAPS, POTENTIAL HAZARDS OF COPPER AZIDE DEPOSITS, FORMATION RATES OF COPPER AZIDE, THE FEASIBILITY OF STAINLESS STEEL AS A POTENTIAL GROUND STRAP MATERIAL AND OTHER POTENTIAL HAZARDS. ONE STUDY REVEALED THERE ARE OTHER METALS, POTENTIALLY UTILIZED IN INSTRUMENT DESIGNS, THAT MAY FORM AN UNSTABLE AZIDE COMPOUND ARE GOLD, SILVER, COPPER, BRASS AND TIN. (B)(4) PERFORMED A STUDY TO DETERMINE THE VIABILITY OF STEEL AND TIN AS REPLACEMENT FOR COPPER. THE STUDY INDICATED THERE ARE NO KNOWN EXPLOSIVE AZIDES FORMED IF STEEL, WITH A SIGNIFICANT AMOUNT OF NICKEL AND CHROMIUM, COMES IN CONTACT WITH THE BUFFER SOLUTION. A GLOBAL ASSESSMENT OF SODIUM AZIDE WAS CONDUCTED. OTHER PARTS IDENTIFIED AS CONTAINING COPPER WILL BE REPLACED WITH OTHER MATERIAL WITH NO KNOWN POTENTIAL VOLATILE METAL FORMATIONS. INSTRUMENT DESIGNS WILL AVOID THE USE OF BARE COPPER OR TIN COATED COPPER IN AREAS WHERE SIGNIFICANT EXPOSURE TO SODIUM AZIDE MIGHT BE EXPECTED. CORRECTIVE ACTIONS WERE IMPLEMENTED IN RESPONSE TO THIS ISSUE. THE MATERIAL OF THE GROUND STRAP WAS CHANGED TO A (B)(4). A MANDATORY TECHNICAL SERVICE BULLETIN REQUIRED THAT EVERY (B)(4) GROUND STRAP BE REPLACED BY FIELD SERVICE TO THE NEW (B)(4) STRAP. IN ADDITION TO THE IMPLEMENTATION OF A (B)(4) WZ MECHANISM GROUND STRAP, INSTRUCTIONS ON THE REMOVAL AND PACKAGING OF POTENTIALLY CORRODED GROUP STRAPS WERE INCORPORATED INTO LABELING. A REVIEW OF COMPLAINT TRACKING AND TRENDING FROM (B)(4) 2009 TO (B)(4) 2010 INDICATED THAT THERE WERE NO COMPLAINTS WITH RESPECT TO CORROSION OR ADVERSE EVENTS IN CONJUNCTIONS WITH THE REPLACEMENT (B)(4) ARCHITECT WASH ZONE MECHANISM GROUND STRAP. PRODUCT LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE POTENTIAL HAZARDS INVOLVED WITH PRODUCTS CONTAINING SODIUM AZIDE; HOWEVER, LABELING WAS ENHANCED TO INCLUDE REFERENCE TO NIOSH, THE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH.

    Description of Event or Problem · 1

    DURING THE EXECUTION OF THE TECHNICAL SERVICE BULLETIN, THE FIELD SERVICE ENGINEER OBSERVED CORROSION ON THE ARCHITECT GROUND STRAP. THE GROUND STRAP WAS REPLACED WITHOUT INCIDENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 WASH ZONE MECH. GROUND STRAP, LN 7-201369-01