BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000RT

    MDR report key: 4260687 · Received November 19, 2014

    Report

    Report Number
    3005248192-2014-00075
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    October 23, 2014
    Report Date
    October 23, 2014
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF ELEVATED COMPLAINT INVESTIGATION (ECINV) NUMBER (B)(4) FOR MDR 3005248192-2014-00075 FOLLOW-UP REPORT 1: EXECUTIVE SUMMARY INVESTIGATION INTO THIS COMPLAINT INCLUDED A QUALITY DATA REVIEW, A PRODUCT EVALUATION, AND A COMPLAINT HISTORY REVIEW. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: QUALITY DATA REVIEW: A NON-CONFORMANCE AND CAPA SEARCH WAS PERFORMED FOR THE M2000RT INSTRUMENT SYSTEM (LN 09K15-01) AND THE ASSY, BLOCK DRIVE AIRJUICE (PN 50-148432). THE SEARCHES RESULTED IN NO RECORDS RELATED TO THIS COMPLAINT INVESTIGATION. A SERVICE HISTORY REVIEW FOR THE M2000RT INSTRUMENT SYSTEM LN 09K15-01 SN (B)(4) WAS CONDUCTED. NO ISSUES WHERE DOCUMENTED AT THE TIME OF INSTALLATION OF THE M2000RT INSTRUMENT SYSTEM LN 09K15-01 SN (B)(4). THERE WERE NO ISSUES LISTED WITHIN THE TICKET SERVICE HISTORY THAT WOULD LEAD TO FAILURE OF THE ASSY, BLOCK DRIVE AIRJUICE, PN 50-148432. PRODUCT EVALUATION: CUSTOMER RETURNS WERE AVAILABLE FOR TICKET (B)(4). HOWEVER, THE PHOTOGRAPHS OF THE FAILED PART ATTACHED TO THE COMPLAINT TICKET WERE SUFFICIENT TO CONDUCT THE INVESTIGATION. RETAIN TESTING IS NOT APPLICABLE. BASED ON INSPECTION OF THE PHOTOGRAPH ATTACHED TO COMPLAINT TICKET (SEE MDR 3005248192-2014-00075 FOLLOW-UP REPORT 1 ATTACHMENT 1), THE OVERHEATING WAS LOCALIZED TO A CIRCUIT BOARD TRACE FROM CONNECTOR TB1 ON THE BLOCK INTERFACE PCA, PN 4343780 WHICH IS A COMPONENT OF THE ASSY, BLOCK DRIVE AIRJUICE, PN 50-148432. NO SMOKE OR SOOT WAS OBSERVED EXTERNAL TO THE SUSPECT M2000RT INSTRUMENT AND THE DAMAGE WAS CONTAINED WITHIN THE M2000RT METAL ENCLOSURE. THEREFORE, THIS INSTRUMENT IS STILL MEETING APPLICABLE SAFETY STANDARDS. THE M2000RT SYSTEM IS CERTIFIED TO THE US, (B)(4) AND INTERNATIONAL SAFETY STANDARDS THAT APPLY TO ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE BY A NATIONALLY RECOGNIZED TESTING LABORATORY. THE OBJECTIVE OF THE SAFETY STANDARDS AS RELATED TO FIRE IS TO ENSURE THAT THE DESIGN AND METHODS OF CONSTRUCTION PROVIDE ADEQUATE PROTECTION FOR THE OPERATOR AND THE SURROUNDING AREA AGAINST SPREAD OF FIRE FROM THE EQUIPMENT.' THE SPECIFIC PARAGRAPH IN SAFETY STANDARD IEC61010-1:2001 IS CLAUSE 9. CLAUSE 9 STATES, "THERE SHALL BE NO SPREAD OF FIRE OUTSIDE THE EQUIPMENT IN NORMAL CONDITION OR IN SINGLE FAULT CONDITION." COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW SHOWED THAT, OVER THE LAST 2 YEARS, THE ELEVATED COMPLAINT ((B)(4)) AND ONE ADDITIONAL COMPLAINT ((B)(4)) WERE THE ONLY COMPLAINTS FOUND TO BE RELATED TO THE ISSUE OF ANY PRE (POTENTIALLY REPORTABLE EVENT) FLAGS SET AS A RESULT OF SMOKE, DISCOLORATION, OR FIRE OCCURRING ON THE M2000RT INSTRUMENT SYSTEM (LN 9K15-01) SPECIFICALLY ON THE ASSY BLOCK DRIVE (PN 50-148432). PRODUCT DEFICIENCY DECISION BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR THE M2000RT INSTRUMENT SYSTEM OR THE ASSY, BLOCK DRIVE AIRJUICE; PART NUMBER 50-148432 WAS NOT IDENTIFIED. THEREFORE, THIS COMPLAINT WILL BE DISPOSITIONED AS UNCONFIRMED. (B)(4)

    Additional Manufacturer Narrative · 1

    AN ELEVATED COMPLAINT INVESTIGATION 4272-ECINV 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.

    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 THAT THE M2000RT INSTRUMENT SMELLED BRAISED DURING A RUN. A FEW MINUTES LATER THE RUN FAILED WITH EC6299 "THERMAL CYCLER FAILED TO REACH A SETPOINT IN TIME". THE CUSTOMER TOOK OUT THE PCR PLATE WHICH LOOKED NORMAL. THE CUSTOMER SWITCHED OFF THE M2000RT INSTRUMENT. AN ABBOTT FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE AND OBSERVED A BURNED SPOT ON THE BLOCK DRIVE BOARD. THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751509 ABBOTT M2000RT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1