BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000SP

    MDR report key: 3715273 · Received March 31, 2014

    Report

    Report Number
    3005248192-2014-00003
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    August 17, 2012
    Report Date
    August 17, 2012
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIBED IN MDR OCCURRED IN (B)(6) 2012. THE PURPOSE OF THIS MDR IS TO RETROSPECTIVELY REPORT THE EVENT. IN (B)(6) 2014, AN ABBOTT MOLECULAR INTERNAL REVIEW FOUND THAT THE ORIGINAL DOCUMENTATION OF THIS EVENT WAS NOT PROCESSED THROUGH THE ABBOTT MOLECULAR COMPLAINT HANDLING SYSTEM AS INTENDED, PER ABBOTT MOLECULAR PROCEDURE. A TECHNICAL EVALUATION DETERMINED THAT THE INCIDENT DESCRIBED IN MDR IS LINKED TO A PREVIOUSLY IDENTIFIED ISSUE FOR WHICH ABBOTT MOLECULAR TOOK FIELD ACTION (B)(4) / FDA RECALL NUMBER Z-0365-2012. SEE ATTACHMENT 1 ((B)(4) CAPA EXECUTIVE SUMMARY) FOR ADDITIONAL INFORMATION. THE FOLLOWING MDR'S WERE ALSO FILED: MDR 3005248192-2011-00012, MDR 3005248192-2011-00014, MDR 3005248192-2011-00015, MDR 3005248192-2011-00016, MDR 3005248192-2011-00017, MDR 3005248192-2011-00018, MDR 3005248192-2011-00019, MDR 3005248192-2011-00020, MDR 3005248192-2011-00021, MDR 3005248192-2011-00022, MDR 3005248192-2011-00024, MDR 3005248192-2011-00025, MDR 3005248192-2011-00026, MDR 3005248192-2011-00027, MDR 3005248192-2011-00028, MDR 3005248192-2011-00029, MDR 3005248192-2011-00030, MDR 3005248192-2011-00031, MDR 3005248192-2011-00032, MDR 3005248192-2011-00034, MDR 3005248192-2011-00035, MDR 3005248192-2012-00001, MDR 3005248192-2012-00002, MDR 3005248192-2012-00003, MDR 3005248192-2012-00007, MDR 3005248192-2012-00011, MDR 3005248192-2012-00016, MDR 3005248192-2012-00017, MDR 3005248192-2012-00021, MDR 3005248192-2012-00022, MDR 3005248192-2012-00023, MDR 3005248192-2013-00002.

    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. ON (B)(6) 2012, AN ABBOTT MOLECULAR FIELD SERVICE ENGINEER (FSE) PERFORMED AN INSPECTION OF AN M2000SP INSTRUMENT, PER INSTRUMENT SERVICE ADVISORY (ISA) M2KSP-020B AND FOUND THAT THE LIQUID WASTE SENSOR HOUSING WAS DEFORMED. THE LIQUID WASTE SENSOR HOUSING WAS REPLACED AS A PRECAUTION BECAUSE IT MET THE REPLACEMENT CRITERIA PER ISA M2KSP-020B. A DEFORMED LIQUID WASTE SENSOR, IN COMBINATION WITH OTHER FACTORS, HAD THE POTENTIAL TO LEAD TO OVERHEATING AND/OR FIRE OF THE SENSOR. NO EVIDENCE OF OVERHEATING/FIRE OR INJURY WAS REPORTED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188062 ABBOTT M2000SP CLINICAL SAMPLE CONCENTRATOR JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1