BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000RT

    MDR report key: 4954812 · Received July 30, 2015

    Report

    Report Number
    3005248192-2015-00016
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 8, 2015
    Report Date
    September 4, 2015
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF ELEVATED COMPLAINT INVESTIGATION (ECINV) (B)(4)-ECINV FOR MDR 3005248192-2015-00016 FOLLOW-UP REPORT 1: INVESTIGATION INTO THIS COMPLAINT INCLUDED AN EXISTING DATA REVIEW, QUALITY DATA REVIEW, A PRODUCT LABELING REVIEW, A PRODUCT EVALUATION, A COMPLAINT HISTORY REVIEW, AND A SERVICE HISTORY REVIEW TO DETERMINE A PRODUCT DEFICIENCY DECISION. EXISTING DATA REVIEW: PHOTOS WERE UNABLE TO BE OBTAINED FROM THIS REMOTE SITE. INFORMATION WITHIN (B)(4) WAS REVIEWED. SUPPORTING INFORMATION PROVIDED BY THE FIELD SERVICE ENGINEER (FSE) WAS DOCUMENTED AND ANALYZED. THE PCA MICROCONTROLLER (PN 8-200739-01) CONNECTOR (J11) HAD MINIMAL DISCOLORATION COMPARED TO THE MATING CONNECTOR ON THE LAMP-GEMINI BOARD CABLE WITH CONNECTOR (PN 50-148387). THE FSE CONFIRMED THAT THE PCA MICROCONTROLLER (PN 8-200739-01) WAS NOT REPLACED. THE ABBOTT M2000RT OPERATIONS MANUAL (PN 200680-107-NOVEMBER 2014) REVIEW SHOWS SUFFICIENT INFORMATION EXISTS FOR THE CUSTOMER TROUBLESHOOT ERROR CODE 4448. THE ABBO M2000RT SERVICE MANUAL (PN 201000-105 - OCTOBER 2011) REVIEW CONCLUDES SUFFICIENT INSTRUCTIONS EXIST FOR THE FSE TO TROUBLESHOOT ERROR CODE 4448.ISA 610-028 M2000RT LAMP TROUBLESHOOTING AND REPLACEMENT PROCEDURES REVIEW CONCLUDES SUFFICIENT INSTRUCTIONS EXIST FOR THE FSE TO TROUBLESHOOT ERROR CODE 4448. QUALITY DATA REVIEW: A SERVICE HISTORY REVIEW WAS PERFORMED FOR M2000RT INSTRUMENT SYSTEM, LN 09K15-01 (SN (B)(4)) INDICATING A SUCCESSFUL INSTALLATION OF THE M2000RT INSTRUMENT SYSTEM AND ONLY THIS INSTANCE OF THE LAMP - GEMINI BOARD CABLE WITH CONNECTOR (PN 50-148387) NEEDING TO BE REPLACED DUE TO DISCOLORATION/BROWNING/BURNING OF THE LAMP CABLE CONNECTOR. PRODUCT/SYSTEM/INSTRUMENT EVALUATION: THE LAMP-GEMINI BOARD CABLE WITH CONNECTOR (PN 50-148387) WAS NOT AVAILABLE FOR RETURN AND PHOTOGRAPHS WERE NOT AVAILABLE FOR REVIEW. THE DESCRIPTION IN THE COMPLAINT TICKET INDICATES THE LAMP-GEMINI BOARD CABLE WITH CONNECTOR (PN 50-148387) APPEARED TO BE BURNED AT THE POINT OF CONNECTION TO THE PCA MICROCONTROLLER. THE LAMP-GEMINI BOARD CABLE WITH CONNECTOR (PN 50-148387) PLUGS INTO THE PCA MICROCONTROLLER (PN 8-200739-01) AT CONNECTOR J11. ADDITIONAL SUPPORTING INFORMATION WAS PROVIDED BY THE FSE INDICATING THE PCA MICROCONTROLLER (PN 8-200739-01) CONNECTOR (J11) HAD MINIMAL DISCOLORATION COMPARED TO THE MATING CONNECTOR ON THE LAMP-GEMINI BOARD CABLE WITH CONNECTOR (PN 50-148387). IF FIRE HAD OCCURRED, BOTH THE PCA MICROCONTROLLER CONNECTOR J11 AND THE MATING CONNECTOR ON THE LAMP-GEMINI BOARD CABLE WITH CONNECTOR (PN 50-148387) WOULD LIKELY HAVE BEEN EQUALLY DAMAGED. THE PCA MICROCONTROLLER (PN 8-200739-01) DID NOT REQUIRE REPLACEMENT BECAUSE IT WAS NOT DAMAGED INDICATING FIRE WAS IMPROBABLE. BASED ON THE DESCRIPTION IN THE COMPLAINT TICKET, AND ADDITIONAL SUPPORTING INFORMATION PROVIDED BY THE FSE VIA EMAIL, THIS IS LIKELY DISCOLORATION DUE TO PROLONGED LOCALIZED HEATING OF THE LAMP-GEMINI BOARD CABLE WITH CONNECTOR (PN 50-148387) WHICH IS A KNOWN ISSUE ADDRESSED BY ISA 610-028 M2000RT LAMP TROUBLESHOOTING AND REPLACEMENT PROCEDURES. THE M2000RT INSTRUMENT SYSTEM (LN 9K15-01) MEETS REQUIRED SAFETY CERTIFICATIONS. THE LAMP - GEMINI BOARD CABLE WITH CONNECTOR (50-148387) IS CONTAINED INSIDE A METAL ENCLOSURE PER REQUIRED SAFETY STANDARDS. IF FIRE DID OCCUR, IT WOULD HAVE BEEN CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT FUNCTIONED AS DESIGNED AND FAILED SAFE. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW SHOWED THAT, OVER THE LAST 2 YEARS, THE ELEVATED (B)(4) AND ONE ADDITIONAL COMPLAINT WERE RELATED TO THE ISSUE OF ANY PRE FLAGS SET AS A RESULT OF SMOKE, DISCOLORATION, OR FIRE OCCURRING ON THE M2000RT INSTRUMENT SYSTEM (09K15-01). (B)(4). ISA 610-028 M2000RT LAMP TROUBLESHOOTING AND REPLACEMENT PROCEDURES INSTRUCTS THE FSE TO REPLACE THE LAMP - GEMINI BOARD CABLE WITH CONNECTOR IF BROWNING OR DISCOLORATION OF THE CONNECTOR IS OBSERVED. REGULAR REPLACEMENT OF THE LAMP - GEMINI BOARD CABLE WITH CONNECTOR IS EXPECTED. (B)(4). PRODUCT DEFICIENCY DECISION: THE INSTRUMENT MEETS REQUIRED SAFETY CERTIFICATIONS. THE ISSUE WAS CONTAINED WITHIN THE METAL ENCLOSURE AND FAILED SAFE. BASED ON THE RESULTS OF THE INVESTIGATION, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ELEVATED COMPLAINT INVESTIGATION (B)(4) 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 A FAILED RUN ON AN M2000RT INSTRUMENT DUE TO ERROR CODE 4448 (= EXCESSIVE NOISE WAS DETECTED IN THE REFERENCE SIGNAL) ON ALL SAMPLES. A FIELD SERVICE SPECIALIST (FSS) SERVICED THE INSTRUMENT AND OBSERVED THE GEMINI BOARD CABLE CONNECTOR BURNT AT POINT OF CONNECTION TO THE BOARD, EVIDENCE OF OVERHEATING. THE CABLE WAS REPLACED. DIAGNOSTIC CHECKS INCLUDED LAMP SOCKET CONNECTION AND LAMP CURRENT CHECKS. THE FSE RETURNED THE M2000RT TO ITS OPERATIONAL STATE. THERE WAS NO DEATH OR INJURY REPORTED. THIS INCIDENT IS REPORTED ON THE BASIS OF THE POTENTIAL FOR DEATH OR SERIOUS INJURY SHOULD THE INCIDENT RECUR. AN ELEVATED COMPLAINT INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498371 ABBOTT M2000RT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1