BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000RT

    MDR report key: 4225568 · Received November 4, 2014

    Report

    Report Number
    3005248192-2014-00070
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF ELEVATED COMPLAINT INVESTIGATION ((B)(4) FOR MDR 3005248192-2014-00070_FOLLOW-UP REPORT 1: USE OF AN UNINTERRUPTIBLE POWER SUPPLY (UPS) IS OPTIONAL BUT RECOMMENDED FOR THE M2000RT INSTRUMENT. THE UPS THAT IS THE SUBJECT OF THIS COMPLAINT WAS NOT PROVIDED BY ABBOTT MOLECULAR. THE UPS LABEL IDENTIFIES A MANUFACTURER FROM (B)(6). MODEL POWER LAN + 9A15, OCC12093. THE PURPOSE OF THE ELEVATED COMPLAINT INVESTIGATION PERFORMED BY ABBOTT MOLECULAR WAS TO DETERMINE IF ABBOTT MOLECULAR PROVIDED ADEQUATE INSTRUCTIONS AND SPECIFICATIONS REGARDING ELECTRICAL REQUIREMENTS FOR A UPS CONNECTION TO THE M2000RT INSTRUMENT. INVESTIGATION INTO THIS COMPLAINT INCLUDED A QUALITY DATA REVIEW AND AN INSTRUMENT COMPLAINT HISTORY REVIEW. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: QUALITY DATA REVIEW: M2000RT OPERATIONS MANUAL 200680-106 - OCTOBER 2012, WAS REVIEWED FOR M2000RT INSTRUMENT SYSTEM COMPLIANCE WITH SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMC) STANDARDS AND PERFORMANCE CHARACTERISTICS AND SPECIFICATIONS. M2000RT SERVICE MANUAL 201000-105 - OCTOBER 2011, WAS REVIEWED FOR ELECTRICAL REQUIREMENTS FOR THE M2000RT INSTRUMENT SYSTEM AND AUXILIARY UNINTERRUPTIBLE POWER SUPPLIES (UPS). BASED ON THE SERVICE HISTORY REVIEW, THE M2000RT INSTRUMENT SN (B)(4) WAS IN PROPER WORKING ORDER AT THE TIME THE ISSUE OF 'UPS FAILURE' WAS OBSERVED. THERE WERE NO M2000RT INSTRUMENT ISSUES LISTED WITHIN THE TICKET SERVICE HISTORY THAT WOULD LEAD TO THE CURRENT UPS AT THE CUSTOMER SITE FAILING. INVESTIGATION VERIFIED ADEQUATE SPECIFICATIONS AND INSTRUCTIONS WERE PROVIDED FOR SELECTION OF UPS TO BE USED WITH THE M2000RT INSTRUMENT. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW SHOWED THAT, OVER THE LAST 2 YEARS, THE ELEVATED COMPLAINT (B)(4) IS THE ONLY COMPLAINT FOUND TO BE RELATED TO THE PRE ISSUE OF AN EXTERNAL UNINTERRUPTIBLE POWER SUPPLY (UPS) EMITTING FUMES/SMOKE WHILE CONNECTED TO THE M2000RT (9K15) INSTRUMENT SYSTEM. PRODUCT DEFICIENCY DECISION: BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, SUFFICIENT LABELING IS PROVIDED IN THE ABBOTT MOLECULAR M2000RT DEVICE REGARDING ELECTRICAL REQUIREMENTS FOR UNINTERRUPTIBLE POWER SUPPLIES (UPS) FOR CONNECTION TO THE M2000RT INSTRUMENT. THEREFORE, THE DISPOSITION OF THIS COMPLAINT WAS UNCONFIRMED.

    Description of Event or Problem · 1

    THE ABBOTT M2000 REALTIME SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED OF THE ABBOTT M2000SP AND ABBOTT M2000RT INSTRUMENTS. THE ABBOTT M2000SP INSTRUMENT IS AN AUTOMATED FLUID HANDLING SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR NUCLEIC ACID TESTING. THE ABBOTT M2000RT SYSTEM SOFTWARE IS AN AUTOMATED SYSTEM FOR PERFORMING FLUORESCENCE-BASED PCR THAT RESULTS IN QUANTITATIVE AND QUALITATIVE DETECTION OF NUCLEIC ACID SEQUENCES. A CUSTOMER REPORTED A BURNING SMELL AND OBSERVED SMOKE (NO FIRE) COMING FROM THE UNIVERSAL POWER SUPPLY (UPS) UNIT CONNECTED TO THE ABBOTT M2000RT INSTRUMENT. THE CUSTOMER TURNED OFF THE ELECTRICITY IN THE LAB, DISCONNECTED THE UPS FROM THE WALL OUTLET, AND LEFT THE LAB TO ALLOW SMOKE TO VENTILATE AND CLEAR UP. ELECTRICITY WAS RECONNECTED, AND THE ABBOTT M2000RT INSTRUMENT RESUMED NORMAL FUNCTION. THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THIS COMPLAINT. AN ELEVATED COMPLAINT INVESTIGATION IS IN PROGRESS. IT IS UNKNOWN AT THIS TIME IF THIS OBSERVATION WAS CAUSED BY AN ABBOTT PRODUCT MALFUNCTION. IF AN ABBOTT PRODUCT MALFUNCTION IS IDENTIFIED THEN FURTHER EVALUATION WILL DETERMINE IF RECURRENCE OF THE MALFUNCTION IS LIKELY TO CAUSE DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705334 ABBOTT M2000RT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1