BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M2000SP ABBOTT INSTRUMENT E-SERIES

    MDR report key: 2827646 · Received November 9, 2012

    Report

    Report Number
    3005248192-2012-00025
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT MOLECULAR ISSUED A VOLUNTARY RECALL ON DECEMBER 4, 2012 AS A RESULT OF THE ISSUE DESCRIBED IN MDR 3005248192-2012-00025. THE FDA (B)(4) DISTRICT OFFICE WAS NOTIFIED OF THE FIELD ACTION (B)(4). THE NOTIFICATION LETTER CONTAINED SOLUTIONS FOR THE CUSTOMER TO FOLLOW UNTIL AN UPGRADE TO THE M2000SP SOFTWARE CAN BE INSTALLED. ABBOTT MOLECULAR ESTIMATES THIS SOFTWARE VERSION WILL BE AVAILABLE BY THE END OF FIRST QUARTER 2013.

    Description of Event or Problem · 1

    THE ABBOTT M2000 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 FLOUORESCENCE-BASED PCR THAT RESULTS IN QUANTITATIVE AND QUALITATIVE DETECTION OF NUCLEIC ACID SEQUENCES. INCORRECT REALTIME HCV CALIBRATOR CONCENTRATION VALUES ENTERED IN THE ABBOTT M2000SP WERE TRANSFERRED TO THE ABBOTT M2000RT, EVEN THOUGH THE VALUES WERE MANUALLY CORRECTED BEFORE STARTING SAMPLE EXTRACTION. THE CUSTOMER WAS PERFORMING A CLINICAL TRIAL AND WAS RUNNING A PROFICIENCY PANEL IN THIS RUN, NOT PATIENT SAMPLES. THE CUSTOMER HAD LAB PROCEDURES IN PLACE THAT IDENTIFIED THAT THE CALIBRATOR CONCENTRATION VALUES WERE INCORRECT. NO RESULTS WERE REPORTED USING THE CALIBRATION RUN THAT INCLUDED INCORRECT CALIBRATOR CONCENTRATION VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2000SP ABBOTT INSTRUMENT E-SERIES STATION, PIPETTING AND DILUTING, FOR CLINICAL USE JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1