BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT M2000SP

    MDR report key: 4182531 · Received October 17, 2014

    Report

    Report Number
    3005248192-2014-00063
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELEVATED COMPLAINT INVESTIGATION (ECINV) FOR (B)(4) DETERMINED THIS COMPLAINT IS THE SAME ISSUE AS THAT OF (B)(4). 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 (B)(4) 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 NUMBER10649045. 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, (B)(4) 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 (B)(4), 2013 THERE WAS AN OCCURRENCE RATE OF (B)(4) COMPLAINTS OVER THE LAST TWO YEARS. ELEVATED COMPLAINT INVESTIGATION (B)(4) CONCLUDED THERE WAS A CONFIRMED PRODUCT DEFICIENCY WITH THE X-DRIVE MOTOR PART NUMBER (B)(4). 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 DISTRICT RECALL COORDINATOR. THE PURPOSE OF SUBMITTING MDR 3005248192-2014-00063 IS TO RETROSPECTIVELY REPORT THIS COMPLAINT BECAUSE IT IS ASSOCIATED WITH REPORTABLE FIELD ACTION FA-CAM-NOV2013-177 (806 REPORT NUMBER 3005248192-07/28/2014-002-C). TO DATE, AN FDA RECALL NUMBER HAS NOT BEEN RECEIVED. . THE FOLLOWING MDR'S 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.

    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. 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 FAILED INSPECTION PER TSB 606-041 AND 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 (B)(4) CONFIRMED THAT THIS COMPLAINT IS LINKED TO A KNOWN PRODUCT MALFUNCTION OF THE X-DRIVE MOTOR. 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
    661192 ABBOTT M2000SP CLINICAL SAMPLE CONCENTRATOR JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1