BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000SP

    MDR report key: 4242790 · Received November 11, 2014

    Report

    Report Number
    3005248192-2014-00071
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 3, 2014
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELEVATED COMPLAINT INVESTIGATION (ECINV) FOR 4264-ECINV DETERMINED THIS COMPLAINT IS THE SAME ISSUE AS THAT OF 3853-ECINV. SUMMARY OF ELEVATED COMPLAINT INVESTIGATION 3853-ECINV: 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. COMPLAINT HISTORY REVIEW SHOWED THAT, OVER THE LAST TWO YEARS, THIRTEEN COMPLAINTS INCLUDING THE SUSPECT COMPLAINTS (B)(4) WERE FOUND TO BE RELATED TO THE ISSUE OF THE X-DRIVE MOTOR FAILING ON THE M2000SP. THEREFORE, AS OF NOVEMBER 20, 2013 THERE WAS AN OCCURRENCE RATE OF THIRTEEN COMPLAINTS OVER THE LAST TWO YEARS. ELEVATED COMPLAINT INVESTIGATION 3853-ECINV 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 (B)(4) 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 3005248192-2014-00071, 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.

    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 LIQUID HANDLING ARM (LIHA) IS A MECHANICAL COMPONENT OF THE M24SP INSTRUMENT THAT PIPETTES AND DISPENSES SAMPLES AND REAGENTS. THE ROBOTIC MANIPULATOR ARM (ROMA) IS ALSO A MECHANICAL COMPONENT EQUIPPED WITH GRIPPER FINGERS WHICH MOVE THE 1 ML SUBSYSTEM CARRIER AND DISPOSABLE TIP RACKS TO DIFFERENT POSITIONS ON THE WORKTABLE. A CUSTOMER REPORTED A FAILURE DURING INITIALIZATION OF THE ROBOTIC MANIPULATOR AND REPORTED THAT THE ROMA BELT BROKE. AN ABBOTT FIELD SERVICE ENGINEER (FSE) PERFORMED TECHNICAL SERVICE BULLETIN (TSB) 606-041 "M2000SP X-DRIVE ASSEMBLY BELT INSPECTION AND REPLACEMENT PROCEDURE". THE ROMA BELT WAS REPLACED. THE LIHA BELT PASSED ALL INSPECTION CRITERIA AND DID NOT REQUIRE REPLACEMENT. THERE WAS NOT ANY REPORT OF DEATH OR INJURY. ELEVATED COMPLAINT INVESTIGATION 4264-ECINV CONFIRMED THAT THIS COMPLAINT IS LINKED TO A KNOWN PRODUCT MALFUNCTION OF THE X-DRIVE MOTOR. REFER FOR A SUMMARY OF ORIGINAL ELEVATED COMPLAINT INVESTIGATION 3853-ECINV. 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 (B)(4) PER 21 CFR 806.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725563 ABBOTT M2000SP CLINICAL SAMPLE CONCENTRATOR JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1