BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY M SYSTEM

    MDR report key: 10146084 · Received June 11, 2020

    Report

    Report Number
    3005248192-2020-00013
    Event Type
    Injury
    Date Received
    June 11, 2020
    Date of Event
    May 19, 2020
    Report Date
    July 23, 2020
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OOI
    UDI-DI
    00884999048034
    PMA / PMN Number
    P190025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A NONCONFORMANCE/CAPA HISTORY REVIEW, CUSTOMER DATA REVIEW, ENGINEERING EVALUATION AND A COMPLAINT HISTORY REVIEW. THE INVESTIGATION IS SUMMARIZED AS FOLLOWS: QUALITY DATA REVIEW THE NONCONFORMANCE/CAPA INVESTIGATION SEARCH PERFORMED TO IDENTIFY RELATED RECORDS FOR LN (B)(4). FOUND NO RELATED ENTRIES. PRODUCT/SYSTEM/INSTRUMENT EVALUATION: CUSTOMER DATA REVIEW THE PHOTOGRAPHS FROM THE CUSTOMER DATA REVIEW SHOW THE EDGE OF THE OVERHEAD REAR COVER OF THE ALINITY M SYSTEM AND THE DAMAGE WHERE THE FSE STRUCK THEIR HEAD, AS DESCRIBED IN THE COMPLAINT. ENGINEERING EVALUATION - SAFETY ASSESSMENT IN-HOUSE TESTING OF THREE ALINITY M SYSTEMS, DEMONSTRATED THAT THE EDGE OF THE REAR UPPER PANEL DID NOT CUT THE OUTER SENSING TAPE OF THE SHARPNESS TEST FIXTURE, CONCLUDING NO INJURY WOULD RESULT FROM CONTACT WITH SKIN AND THAT THE EDGE OF THE REAR UPPER PANEL IS SMOOTH AND ROUNDED ENOUGH SO AS TO NOT CAUSE INJURY PER SECTION 7 OF IEC/EN 61010-1. COMPLAINT HISTORY REVIEW COMPLAINT HISTORY REVIEW SHOWED THAT THAT THE ELEVATED COMPLAINT UNDER INVESTIGATION WAS THE ONLY COMPLAINT TICKET RELATED TO AN ALINITY M SYSTEM OPERATOR INJURY DUE TO CONTACT WITH THE REAR UPPER PANEL. BASED ON THE RESULTS OF THE INVESTIGATION, THERE IS NO EVIDENCE OF A PRODUCT DEFICIENCY FOR THE ALINITY M INSTRUMENT SYSTEM, LN (B)(4).

    Additional Manufacturer Narrative · 1

    ELEVATED COMPLAINT INVESTIGATION HAS BEEN INITIATED.

    Description of Event or Problem · 1

    ABBOTT MOLECULAR FIELD SERVICE ENGINEER (FSE) WAS INJURED DURING INSTALLATION OF AN ALINITY M SYSTEM. FSE BUMPED HIS HEAD ON THE REAR UPPER PANEL WHILE WORKING ON THE INSTRUMENT TO REMOVE TRANSIT BRACKETS. FSE HAD TO ATTEND THE EMERGENCY ROOM AND RECEIVED STAPLES/STITCHES FOR A HEAD WOUND. THE SYSTEM IS BRAND NEW AND HAS NEVER BEEN USED TO PROCESS SAMPLES. NO PATIENT IS INVOLVED AS THIS INJURY WAS SUSTAINED BY AN ABBOTT MOLECULAR FIELD SERVICE ENGINEER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605600 ALINITY M SYSTEM REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM OOI ABBOTT MOLECULAR, INC. 00884999048034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention