BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000SP

    MDR report key: 4326923 · Received December 12, 2014

    Report

    Report Number
    3005248192-2014-00079
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    November 17, 2014
    Report Date
    November 17, 2014
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELEVATED COMPLAINT INVESTIGATION (ECINV) FOR 4291-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 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 CHICAGO DISRICT RECALL COORDINATOR. THEREFORE, THE PURPOSE OF SUBMITTING MDR 3005248192-2014-00079 IS TO REPORT THIS COMPLAINT BECAUSE IT IS ASSOCIATED WITH REPORTABLE FIELD ACTION FA-CAM-NOV2013-177 (806 REPORT NUMBER (B)(4). TO DATE, AN FDA RECALL NUMBER HAS NOT BEEN RECEIVED. 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 3005248192-2014-0003,3 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.

    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 M2000SP INSTRUMENT THAT PIPETTES AND DISPENSES SAMPLES AND REAGENTS. THE ROBOTIC MANIPULATOR ARM (ROMA) IS A MECHANICAL COMPONENT OF THE M2000SP INSTRUMENT THAT MOVES THE DISPOSABLE TIP RACKS TO DIFFERENT POSITIONS ON THE WORKTABLE. AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE TO PERFORM 12 MONTH PREVENTIVE MAINTENANCE AND TECHNICAL SERVICE BULLETIN (TSB) 606-041 "M2000SP X-DRIVE ASSEMBLY BELT INSPECTION AND REPLACEMENT PROCEDURE". THE FSE CHECKED THE MOVEMENT OF THE LIHA AND ROMA AND FOUND THAT THE LIHA HAD AN UNUSUAL RATTLING NOISE. THE FSE DETERMINED THAT BOTH THE LIHA AND ROMA X-BELTS SHOWED SIGNS OF CORROSION. THE FSE REPLACED THE LIHA AND ROMA BELTS PER TSB 606-041 WHICH RESOLVED THE RATTLING NOISE. THERE WAS NOT ANY REPORT OF INJURY. ELEVATED COMPLAINT INVESTIGATION 4291-ECINV CONFIRMED THAT THIS COMPLAINT IS LINKED TO A KNOWN PRODUCT MALFUNCTION OF THE X-DRIVE MOTOR. (B)(4). 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
    809050 ABBOTT M2000SP CLINICAL SAMPLE CONCENTRATOR JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1