BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000SP

    MDR report key: 4181529 · Received October 17, 2014

    Report

    Report Number
    3005248192-2014-00062
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF ELEVATED COMPLAINT INVESTIGATION (B)(4) FOR MDR 3005248192-2014-00062 FOLLOW-UP REPORT 1. INVESTIGATION INTO COMPLAINT (B)(4) INCLUDED A QUALITY DATA REVIEW, A PRODUCT EVALUATION, AND A COMPLAINT HISTORY REVIEW. THE RESULTS OF THE INVESTIGATION ELEMENTS ARE SUMMARIZED AS FOLLOWS: QUALITY DATA REVIEW: A SERVICE HISTORY REVIEW OF SN(B)(4) WAS CONDUCTED. NO ISSUES WERE DOCUMENTED AT THE TIME OF INSTALLATION OF THIS M24SP INSTRUMENT SYSTEM. NO INDICATIONS OF FAILURE OF THE PCBA DC SERVO POWER II WERE IDENTIFIED. REVIEW OF THE APPROVED LABELING (M24SP INSTRUMENT SYSTEM OPERATIONS MANUAL) CONFIRMS THE CUSTOMER IS INFORMED OF WHAT TO DO WHEN THEY RECEIVE THE ERROR (LIHA ERROR 5 DEVICE NOT IMPLEMENTED). ADDITIONALLY, THERE ARE INSTRUCTIONS FOR THE FSE TO TROUBLESHOOT THIS ISSUE AND REPLACE BOARDS, AS REQUIRED (M24SP SERVICE MANUAL). A CAPA/NON-CONFORMANCE SEARCH IDENTIFIED (B)(4) AS BEING RELATED TO THIS COMPLAINT. (B)(4) DOCUMENTS THE INVESTIGATION AND RISK ASSESSMENT PERFORMED BY SUPPLIER TECAN, AG AS A RESULT OF UNCONFIRMED COMPLAINT INVESTIGATION (B)(4) FOR EVIDENCE OF BURNING OF THE DC SERVER BOARD (TANTALUM CAPACITOR FAILURE). AT THE TIME OF (B)(4), TECAN STATED THAT THERE WAS A LOW FREQUENCY OF FAILURE AND THE PRODUCT CONFORMS TO SAFETY STANDARD IEC 61010-1 (THE BOARD IS SELF-EXTINGUISHING IN THE CASE OF FIRE). THEREFORE, TECAN CONCLUDED THAT NO FURTHER ACTION WOULD NEED TO BE TAKEN EXCEPT MONITORING OF THE ISSUE. PRODUCT EVALUATION: RETAIN TESTING WAS NOT APPLICABLE AS M24SP INSTRUMENT SYSTEM IS A SERIALIZED DEVICE. RETURN OF THE INSTRUMENT WAS NOT REQUIRED AS ON-SITE SERVICE RESOLVED THE ISSUE. THE ATTACHED PHOTOGRAPHS WERE SUFFICIENT TO UNDERSTAND THE ISSUE AND THEREFORE BOARD RETURN WAS NOT NECESSARY. REVIEW OF PHOTOGRAPHS ATTACHED TO THE COMPLAINT TICKET AND 347-SCAPA IDENTIFIED THE FAILED COMPONENT AS CAPACITOR C46. (B)(4) LISTS C46 AS ONE OF THE ROOT CAUSES OF THE ISSUE. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW SHOWED THAT, OVER THE LAST 2 YEARS, FOUR COMPLAINTS INCLUDING THE SUSPECT COMPLAINT ((B)(4)) WERE FOUND TO BE RELATED TO THE ISSUE OF ANY PRE FLAGS SET AS A RESULT OF SMOKE, DISCOLORATION, OR FIRE OCCURRING ON THE M2000SP E-SERIES (9K14-02) INSTRUMENT, THE M24SP INSTRUMENT SYSTEM (03N06-01), OR PLEX-ID FLUID HANDLER (03N31-50) SPECIFICALLY THE DC SERVO II BOARD. CONCLUSION OF PRODUCT DEFICIENCY DECISION: BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THE M24SP INSTRUMENT SYSTEM LN 03N06-01 OR ANY ABBOTT MOLECULAR PRODUCTS CONTAINING PCBA DC SERVO POWER II (10649012) CIRCUIT BOARD OR PCBA DC SERVO II (10649011) CIRCUIT BOARD. NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER OBSERVATION OF A CHAR MARK ON THE DC SERVO POWER BOARD IS CONSIDERED AS "EVIDENCE OF FIRE" PER ABBOTT PROCEDURE AND IS REPORTABLE IN THE ABSENCE OF OBJECTIVE EVIDENCE THAT ELIMINATES THE ABBOTT DEVICE AS CAUSING OR CONTRIBUTING TO THE MALFUNCTION OR EFFECTS. ELEVATED COMPLAINT INVESTIGATION (B)(4) IS IN PROCESS.

    Description of Event or Problem · 1

    THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID AMPLIFICATION TESTING BY POLYMERASE CHAIN REACTION IN CLINICAL LABORATORIES. THE SYSTEM IS COMPOSED OF THE M2000RT AND THE M2000SP INSTRUMENTS. THE M2000SP IS INTENDED FOR AUTOMATED SAMPLE PREPARATION AND NUCLEIC ACID EXTRACTION PRIOR TO TESTING. THE INSTRUMENT INVOLVED IN THIS COMPLAINT IS AN ABBOTT M24SP INSTRUMENT (LIST 03N06-01), SERIAL NUMBER (B)(4).THE ABBOTT M24SP IS A CE-MARKED EXTRACTION INSTRUMENT NOT SOLD IN THE UNITED STATES; THIS INCIDENT IS REPORTED ON THE BASIS THAT THE M24SP INSTRUMENT IS SIMILAR TO THE ABBOTT M2000SP INSTRUMENT (LIST 09K14-02) SOLD IN THE UNITED STATES. A CUSTOMER REPORTED THAT THE M24SP INSTRUMENT SUDDENLY STOPPED DURING AN (B)(6) RUN AND DISPLAYED C5 ERROR 5 "DEVICE NOT IMPLEMENTED" ON THE SCREEN. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE LIHA ASSEMBLY AND OBSERVED A CHAR MARK ON THE DC SERVO POWER BOARD. THE FSE REPLACED THE BOARD AND EXECUTED THE VERIFICATION PROCEDURE PER THE SERVICE MANUAL. THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660433 ABBOTT M2000SP CLINICAL SAMPLE CONCENTRATOR JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1