BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT M2000SP INSTRUMENT

    MDR report key: 12325164 · Received August 16, 2021

    Report

    Report Number
    3005248192-2021-00166
    Event Type
    Injury
    Date Received
    August 16, 2021
    Date of Event
    July 21, 2021
    Report Date
    August 16, 2021
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A SUPPORTING INFORMATION REVIEW, CUSTOMER DATA REVIEW, QUALITY DATA REVIEW, AND COMPLAINT HISTORY REVIEW . THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: SUPPORTING INFORMATION REVIEW: M2000SP E-SERIES SERVICE MANUAL 50-608125/R5[?]SEPTEMBER 2018, WAS REVIEWED. REVIEW CONCLUDED THE MANUAL CONTAINS: BIOSAFETY PROCEDURES ARE FIRST LISTED IN THE INTRODUCTION ON PAGE IX, AND BIOLOGICAL AND SAFETY WARNINGS ARE PROVIDED THROUGHOUT THE MANUAL. GENERAL STEPS FOR LIQUID HANDLER (LIHA) (ERROR CODES 3101-3199) ON PAGE 7-67. CUSTOMER DATA REVIEW: PHOTOGRAPHS OF THE PARTIALLY DISASSEMBLED LIHA AND THE INJURY WERE REVIEWED. THE INSTRUMENT LIHA WOULD NOT INITIALIZE AND WAS POWERED-OFF. THE LIHA COVERS WERE REMOVED. INDIVIDUAL CHANNELS WERE MOVED MANUALLY TO CHECK MOTOR COUPLINGS. WHILE MOVING CHANNEL 3 A COUPLING ISSUE WAS SUSPECTED. WHEN FIELD SERVICE ENGINEER (FSE) WAS MOVING HIS HAND UPWARD TO CHECK THE COUPLING FOR CHANNEL 3 THE BACK OF HIS HAND STRUCK THE TUBING EXTENSION AT THE BOTTOM OF THE DITI (DISPOSABLE TIP) CONE ON CHANNEL 8. QUALITY DATA REVIEW: A SEARCH OF NON-CONFORMANCE (NC) AND CAPA (NC/CAPA) RECORDS WAS PERFORMED FOR INSTANCES OF PERSONAL INJURY RELATED TO THE M2000SP INSTRUMENT BASE LIST NUMBER 09K14. THE QUERY FOR BASE LIST NUMBER 09K14 REVEALED NO RECORDS ASSOCIATED WITH BASE LIST NUMBER 9K14 AND THE REPORTED ISSUE. COMPLAINT HISTORY REVIEW: A COMPLAINT SEARCH WAS PERFORMED TO IDENTIFY PAST PRE COMPLAINT TICKETS FOR ANY INSTANCES OF PERSONAL INJURY WHERE AN FSE SCRAPED THE BACK OF HIS HAND ON THE TUBING EXTENSION PROTRUDING FROM DITI CONE 8 WHILE SERVICING THE LIHA ON THE M2000SP INSTRUMENT BASE LIST NUMBER 09K14. COMPLAINT HISTORY REVIEW SHOWED THAT, IN THE PAST TWO YEARS THE ELEVATED COMPLAINT TICKET UNDER CURRENT INVESTIGATION WAS THE ONLY COMPLAINT RELATED TO PERSONAL INJURY ON THE M2000SP INSTRUMENT BASE LIST NUMBER 09K14. BASED ON THE RESULTS OF THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE M2000SP INSTRUMENT (LN 09K14-02).

    Description of Event or Problem · 1

    A FIELD SERVICE ENGINEER SUFFERED AN ABRASION WHILE WORKING ON A REALTIME M2000SP INSTRUMENT. THE CUSTOMER CONTACTED ABBOTT ABOUT AN ERROR 3124 AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE SERVICED THE INSTRUMENT'S LIQUID HANDLING ARM AND HIS HANDS TOUCHED THE DITI CONE AND TUBING EXTENSIONS. HIS GLOVES WERE TORN AND THE BACK OF HIS HAND WAS ABRAISED AND BLEEDING. ENVIRONMENTAL HEALTH AND SAFETY DIRECTED HIM TO CLEAN HIS WOUNDS AND GO TO THE HOSPITAL WHERE HE WAS PRESCRIBED (B)(6) TO PREVENT (B)(6) INFECTION AND HAD OTHER BLOOD WORK DONE. THERE HAVE BEEN NO ADDITIONAL REPORTS OF ANY FURTHER IMPACT TO THE FSE AND NO PRODUCT DEFICIENCY WAS IDENTIFIED DURING THE ELEVATED COMPLAINT INVESTIGATION. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN (B)(6) USING THE M2000SP INSTRUMENT, LIST NUMBER 09K14-02, WHICH IS ALSO APPROVED FOR USE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225972 ABBOTT M2000SP INSTRUMENT CLINICAL SAMPLE CONCENTRATOR JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention