BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000SP

    MDR report key: 4327704 · Received December 13, 2014

    Report

    Report Number
    3005248192-2014-00084
    Event Type
    Malfunction
    Date Received
    December 13, 2014
    Date of Event
    December 4, 2014
    Report Date
    December 4, 2014
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF ELEVATED COMPLAINT INVESTIGATION (B)(4): PROBLEM: EXCESSIVE NOISE FROM THE LIHA AND ROMA X-DRIVE MOTORS WAS REPORTED. NOISE AND STEP-LOSS FAILURES OCCUR WITHIN 2-3 MONTHS OF INSTRUMENT INSTALLATION OR REPLACEMENT SPARE PART INSTALLATION. CONCLUSIONS: RETAIN TESTING OF THE X-DRIVE MOTOR WAS NOT APPLICABLE AS NO FILE SAMPLES ARE RETAINED. SUPPLIER TECAN HAS CONFIRMED A PRODUCT DEFICIENCY WITH THE DRIVE BELT PRODUCTION PROCESS ON SOME BELTS. WITHIN 2-3 MONTHS OF OPERATION THE BELT TENSION CHANGES LEADING TO EXCESSIVE NOISE AND IN SOME CASES THE ASSOCIATED ARM CRASHES INTO A WORKTABLE OBJECT OR BECOMES MISALIGNED. X-DRIVE AXIS MOTOR REPLACEMENT SPARE PARTS AND ALL M2000SP AND M24SP INSTRUMENTS MANUFACTURED WITH THE ASSEMBLIES WITH DATE CODES BETWEEN 01 JANUARY 2013 THROUGH 30 SEPTEMBER 2013 ARE SUSPECT. THE M2000SP SERVICE MANUAL CONTAINS ADEQUATE INSTRUCTIONS FOR TROUBLESHOOTING X-DRIVE MOTOR ISSUES WITH REPLACEMENT INSTRUCTIONS AND PART NUMBER INFORMATION. VALID MATERIAL SPECIFICATIONS ARE RESIDENT IN PILGRIM SMARTSOLVE FOR THE MOTOR DC ARM X-AXIS 1000 INCREMENTS EVO PART NUMBER 10649045. A THOROUGH COMPLAINT SEARCH WAS PERFORMED TO IDENTIFY PAST COMPLAINT TICKETS FROM THE LAST TWO YEARS FOR ANY INSTANCES OF THE X-DRIVE MOTORS MAKING EXCESSIVE NOISE ON THE M2000SP INSTRUMENT. (B)(4). ELEVATED COMPLAINT INVESTIGATION (B)(4) CONCLUDED THERE WAS A CONFIRMED PRODUCT DEFICIENCY WITH THE X-DRIVE MOTOR PART NUMBER 10649045. ABBOTT MOLECULAR DETERMINED A FIELD ACTION (CORRECTION) SHOULD BE TAKEN TO INSPECT AND, IF NECESSARY, REPLACE THE AFFECTED BELTS. ABBOTT MOLECULAR INITIATED FIELD ACTION NUMBER FA-CAM-NOV2013-177 ON NOVEMBER 23, 2013 AS A RECORDABLE FIELD ACTION. UPON RECEIPT OF FDA 483 OBSERVATION #1 ON JULY 11, 2014, ABBOTT MOLECULAR DETERMINED THIS FIELD ACTION SHOULD HAVE BEEN REPORTED TO FDA PER 21 CFR 806, AND ON JULY 29, 2014 REPORTED IT TO THE FDA (B)(4) DISRICT RECALL COORDINATOR. TO DATE, AN FDA RECALL NUMBER HAS NOT BEEN RECEIVED. IN ADDITION TO MDR 3005248192-2014-00084, THE FOLLOWING MDRS WERE ALSO REPORTED: MDR 3005248192-2014-00007 MDR 3005248192-2014-00008 MDR 3005248192-2014-00009 MDR 3005248192-2014-00010 MDR 3005248192-2014-00011 MDR 3005248192-2014-00012 MDR 3005248192-2014-00013 MDR 3005248192-2014-00014 MDR 3005248192-2014-00015 MDR 3005248192-2014-00016 MDR 3005248192-2014-00017 MDR 3005248192-2014-00018 MDR 3005248192-2014-00019 MDR 3005248192-2014-00020 MDR 3005248192-2014-00021 MDR 3005248192-2014-00022 MDR 3005248192-2014-00023 MDR 3005248192-2014-00024 MDR 3005248192-2014-00025 MDR 3005248192-2014-00026 MDR 3005248192-2014-00027 MDR 3005248192-2014-00028 MDR 3005248192-2014-00029 MDR 3005248192-2014-00030 MDR 3005248192-2014-00031 MDR 3005248192-2014-00032 MDR 3005248192-2014-00033 MDR 3005248192-2014-00034 MDR 3005248192-2014-00035 MDR 3005248192-2014-00036 MDR 3005248192-2014-00037 MDR 3005248192-2014-00038 MDR 3005248192-2014-00039 MDR 3005248192-2014-00040 MDR 3005248192-2014-00041 MDR 3005248192-2014-00042 MDR 3005248192-2014-00043 MDR 3005248192-2014-00044 MDR 3005248192-2014-00045 MDR 3005248192-2014-00046 MDR 3005248192-2014-00047 MDR 3005248192-2014-00048 MDR 3005248192-2014-00049 MDR 3005248192-2014-00050 MDR 3005248192-2014-00051 MDR 3005248192-2014-00052 MDR 3005248192-2014-00053 MDR 3005248192-2014-00054 MDR 3005248192-2014-00055 MDR 3005248192-2014-00058 MDR 3005248192-2014-00059 MDR 3005248192-2014-00060 MDR 3005248192-2014-00063 MDR 3005248192-2014-00064 MDR 3005248192-2014-00065 MDR 3005248192-2014-00071 MDR 3005248192-2014-00072 MDR 3005248192-2014-00076 MDR 3005248192-2014-00077 MDR 3005248192-2014-00078 MDR 3005248192-2014-00079 MDR 3005248192-2014-00080 MDR 3005248192-2014-00081 MDR 3005248192-2014-00082 MDR 3005248192-2014-00083

    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 (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 (B)(4)) SOLD IN THE UNITED STATES. THE LIQUID HANDLING ARM (LIHA) IS A MECHANICAL COMPONENT OF THE M24SP AND M2000SP INSTRUMENTS THAT PIPETTES AND DISPENSES SAMPLES AND REAGENTS. THE ROBOTIC MANIPULATOR ARM (ROMA) MOVES THE DISPOSABLE TIP RACKS TO DIFFERENT POSITIONS ON THE WORKTABLE. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO PERFORM TECHNICAL SERVICE BULLETIN (TSB) 601-028 "M24SP X-DRIVE ASSEMBLY BELT INSPECTION AND REPLACEMENT PROCEDURE". THE FSE DETERMINED THAT THE LIHA X-BELT FAILED THE INSPECTION CRITERIA AND WAS REPLACED PER TSB 601-028. THE ROMA BELT PASSED THE INSPECTION CRITERIA AND DID NOT NEED REPLACEMENT. THERE WAS NOT ANY REPORT OF INJURY. MEDICAL EVALUATION CONCLUDED THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS COMPLAINT IS REPORTED IN ACCORDANCE WITH 21 CFR 803 ON THE BASIS IT IS LINKED TO REPORTABLE FIELD ACTION FA-CAM-NOV2013-177 PER 21 CFR 806.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819291 ABBOTT M2000SP CLINICAL SAMPLE CONCENTRATOR JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1