BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMX ANALYZER

    MDR report key: 1344289 · Received March 17, 2009

    Report

    Report Number
    1628664-2009-00114
    Event Type
    Malfunction
    Date Received
    March 17, 2009
    Date of Event
    February 23, 2009
    Report Date
    February 23, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJQ
    PMA / PMN Number
    K864319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER (B)(4) WASH STATION THUMBSCREW AND WASH STATION SHROUD. INVESTIGATION SUMMARY: THE FSR REPLACED MULTIPLE PARTS TO REPAIR THE (B)(4), BUT THE POWER SUPPLY ISSUE COULD NOT BE RESOLVED. THE CUSTOMER TECHNICAL ADVOCATE (CTA) SENT THE CUSTOMER A REPLACEMENT (B)(4) WAS RETURNED TO MANUFACTURER. RETURNED (B)(4) WAS VISUALLY EXAMINED AND WAS FOUND TO HAVE BENT LIQUID HEATER BLOCK POSTS, A CRACKED WASH STATION SHROUD, AND BURNED WIRING. THE (B)(4) OPERATION MANUAL WAS FOUND TO CONTAIN ADEQUATE INFORMATION ON MAINTENANCE AND TROUBLESHOOTING FOR THE (B)(4) WASH STATION. THE MANUAL REPLACEMENT INSTRUCTIONS FOR THE (B)(4) WASH STATION INCLUDE INSTRUCTIONS TO ATTACH THE THUMBSCREW FINGER TIGHT. THE MANUAL NOTES WASH STATION ALIGNMENT IS CRITICAL FOR GOOD WASHING OF THE PROBE AND TO PREVENT SPLASHING. THE MANUAL CONTAINS DIRECTIONS FOR WASH STATION CALIBRATION, AND THE MANUAL NOTES AS REQUIRED MAINTENANCE SHOULD BE PERFORMED TO KEEP THE (B)(4) IN GOOD OPERATING CONDITION. THE MANUAL ALSO CONTAINS INFORMATION ON HAZARDS, AND CONTAINS INFORMATION ON PRECAUTIONS (B)(4) OPERATORS SHOULD FOLLOW TO PREVENT INJURY. UNDER SAFETY, THE MANUAL CAUTIONS THE OPERATOR ABOUT THE RISK OF ELECTRICAL SHOCK. A REVIEW OF COMPLAINT RECORDS FOR THE (B)(4) ANALYZER DID NOT IDENTIFY ANY ADVERSE TRENDS DUE TO THE ISSUE BEING EVALUATED. A MALFUNCTION OF THE (B)(4) WAS IDENTIFIED. THE (B)(4) SUSTAINED POWER SUPPLY WIRING DAMAGE DUE TO BUFFER LEAKAGE, BECAUSE THE WASH STATION WAS NOT HELD STABLE DUE TO THE FAILURE OF WORN PARTS AND A MISSING THUMBSCREW. THE ACTUAL CAUSE OF THE THUMBSCREW AND WASH STATION SHROUD FAILURE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. BASED ON THE AVAILABLE INFORMATION AND THIS EVALUATION, NO DEFICIENCY WAS IDENTIFIED FOR THE (B)(4) WASH STATION THUMBSCREW (B)(4), OR THE (B)(4) ANALYZER LIST NO. 08389-01 RELATED TO THE ISSUE UNDER EVALUATION. THIS IS THE FINAL REPORT.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THERE IS A CRACK IN THE SHROUD WHERE THE WASH STATIONS SCREW HOLDS THE WASH STATION TO THE SHROUD ON THE IMX ANALYZER. THE CUSTOMER REQUESTED SERVICE FOR THIS ISSUE. SERVICE NOTED THAT THE POWER SUPPLY WAS NOT PROVIDING VOLTAGE TO THE HEATERS AND OBSERVED SMOKE WHILE TESTING THE HEATERS. NO FIRE WAS OBSERVED. TWO MORE POWER SUPPLIES HAD SHORTED OUT DURING TROUBLESHOOTING NOTING THAT ALL WIRES WERE BURNT THROUGH DUE TO BUFFER LEAKING AND SHORTING ACROSS THE CABLES. THERE WERE NO INJURIES REPORTED DUE TO THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1