BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000RT

    MDR report key: 2832344 · Received November 14, 2012

    Report

    Report Number
    3005248192-2012-00026
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OOI
    PMA / PMN Number
    K092705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, FDA TELEPHONED ABBOTT MOLECULAR TO BRING TO OUR ATTENTION THAT THE 3500A FORM FOR MDR 3005248192-2012-00026 WAS MISSING THE EVENT DESCRIPTION. ADDITIONALLY, THERE WAS A SINGLE LETTER "T" ENTERED. THE SINGLE LETTER "T" OBSERVED SHOULD HAVE BEEN DELETED. BOTH MISTAKES WERE ATTRIBUTED TO HUMAN ERROR. AN ADDITIONAL STEP TO PREVENT THIS MISTAKE FROM OCCURRING AGAIN IS TO PRINT OUT THE FORM FROM E-SUBMITTER TO CHECK IT BEFORE SUBMITTING IT TO FDA THROUGH WEB TRADER.

    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 FLUORESCENCE-BASED PCR THAT RESULTS IN QUANTITATIVE AND QUALITATIVE DETECTION OF NUCLEIC ACID SEQUENCES. DURING SERVICE ON THE ABBOTT M2000RT SYSTEM SOFTWARE, THE FIELD SERVICE ENGINEER DISASSEMBLED THE HEATED COVER. HE REMOVED THE FRESNEL LENS AND NOTICED A BURNT/CHARRED MARK ON THE LENS ABOVE WELLS A8 AND A9, DIRECTLY ABOVE WHERE THE RIBBON CABLE IS CONNECTED. NO FIRE OR VISIBLE SMOKE WAS OBSERVED. THERE WAS NO REPORT OF INJURY. THE BURNT/CHARRED MARK ON THE LENS IS CONSIDERED TO BE EVIDENCE OF FIRE. EVIDENCE OF FIRE IS CRITERIA FOR AN MDR REPORTABLE EVENT PER ABBOTT MOLECULAR PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1