BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT M2000SP

    MDR report key: 4191453 · Received October 22, 2014

    Report

    Report Number
    3005248192-2014-00066
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 23, 2014
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    PMA / PMN Number
    K092705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ELEVATED COMPLAINT INVESTIGATION (B)(4) WAS OPENED. A FOLLOW-UP MDR REPORT WILL BE SUBMITTED AFTER THE COMPLAINT INVESTIGATION CONCLUDES.

    Additional Manufacturer Narrative · 1

    ELEVATED COMPLAINT INVESTIGATION (B)(4) WAS OPENED TO INVESTIGATE (B)(4) FOR WHICH MDR 3005248192-2014-00066 WAS REPORTED. INVESTIGATION INTO THIS COMPLAINT INCLUDED A QUALITY DATA REVIEW, A PRODUCT EVALUATION, AND A COMPLAINT HISTORY REVIEW. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: QUALITY DATA REVIEW: THE M2000SP OPERATIONS MANUAL 200681-107- JULY 2013 CONTAINS ADEQUATE INFORMATION FOR SETUP AND EXECUTION OF CLOSED-MODE ASSAY SAMPLE PREPARATION AND MASTERMIX ADDITION INCLUDING PIPETTE TIP LOADING AND PIPETTE TIP WASTE REMOVAL. ERROR CODE 3110 DEFINITION, PROBABLE CAUSES AND CORRECTIVE ACTIONS WERE PRESENT. DAILY MAINTENANCE INSTRUCTIONS INCLUDING DITI CONE CLEANING WERE ALSO FOUND. THERE ARE NO PROCEDURES IN THE M2000 OPERATIONS MANUAL THAT INSTRUCT THE USER TO MANUALLY REMOVE DISPOSABLE PIPETTE TIPS FROM THE LIHA. IN ADDITION, INSTRUMENT OPERATORS ARE NOT TRAINED BY ABBOTT MOLECULAR TO MANUALLY REMOVE PIPETTE TIPS FROM THE M2000SP INSTRUMENT (M2000 SYSTEM CUSTOMER TRAINING GUIDE 200857-111-JULY 2013). IF AN ERROR IS NOT RECOVERABLE, THE OPERATOR SHOULD CHOOSE TO "CLOSE PROCESS".CLOSE PROCESS ENDS THE CURRENT PROCESS AND SENDS ALL ROBOTIC ARMS TO THE HOME POSITION. THIS INCLUDES AUTOMATIC REMOVAL OF ANY REMAINING DISPOSABLE PIPETTE TIPS ATTACHED TO THE LIHA. A CAPA/NON-CONFORMANCE REVIEW WAS PERFORMED FOR THE M2000SP INSTRUMENT LIST NUMBER 9K14. NONE OF THE RESULTS WAS RELATED TO PERSONAL INJURY FROM THE DITI CONE OR PIPETTE TIPS WHILE RUNNING THE M2000SP INSTRUMENT. A REVIEW OF INCIDENT REPORTS BY ABBOTT MOLECULAR EHS (EMPLOYEE HEALTH AND SAFETY) DEPARTMENT DID NOT IDENTIFY ANY INJURIES THAT WERE THE RESULT OF AN EMPLOYEE ATTEMPTING TO MANUALLY REMOVE DITI'S MOUNTED ON THE ROBOTIC ARM OF THE M2000SP. SERVICE HISTORY REVIEW FOR SN(B)(4) DID NOT REVEAL ANY CMS NEXT TICKETS CONTAINING POSSIBLE CAUSES FOR THE PERSONAL INJURY. THERE WERE NO OTHER TICKETS FOR LIHA ISSUES. PRODUCT EVALUATION: RETAIN TESTING WAS NOT APPLICABLE AS THE M2000SP INSTRUMENT SYSTEM IS A SERIALIZED DEVICE. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW SHOWED THAT, OVER THE LAST 2 YEARS, ONLY THIS (B)(4) WAS FOUND TO BE RELATED TO THE ISSUE OF ANY PRE FLAGS SET AS A RESULT OF PERSONAL INJURY DURING REMOVAL OF DITIS WHILE OPERATING THE M2000SP (9K14). (B)(4). PRODUCT DEFICIENCY DECISION BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR THE M2000SP INSTRUMENT (09K14-02) SN(B)(4) WAS NOT IDENTIFIED. THEREFORE, THE DISPOSITION OF THIS COMPLAINT WAS UNCONFIRMED.

    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. A TECHNICIAN SUSTAINED A SKIN INJURY ON HER HAND RESULTING IN BLEEDING. THE TECHNICIAN WAS WEARING GLOVES WHICH WERE NOT TORN. INJURY WAS SUSTAINED AFTER THE INSTRUMENT STOPPED AND THE TECHNICIAN WAS MANUALLY REMOVING TIPS, AT THE BOTTOM OF THE DISPOSABLE TIP (DITI) EXTENSION WHICH PROTRUDES SLIGHTLY THROUGH THE DITI CONE. THE DITI CONE WITHIN THE M2000SP CABINET MAY CONTAIN HUMAN SERUM/PLASMA WHICH ARE CLASSIFIED AS POTENTIALLY INFECTIOUS. EXPOSURE MAY LEAD TO AN INFECTION AND ITS CONSEQUENCES. THE INSTRUMENT IN THIS CUSTOMER'S LAB IS USED FOR HCV RNA TESTING. PER THE CUSTOMER'S LABORATORY PROCEDURE, SHE RECEIVED ANTIRETROVIRAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672933 ABBOTT M2000SP CLINICAL SAMPLE CONCENTRATOR JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other