BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY M SYSTEM

    MDR report key: 14597513 · Received June 3, 2022

    Report

    Report Number
    3005248192-2022-00677
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    May 24, 2022
    Report Date
    September 15, 2022
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OOI
    UDI-DI
    00884999048034
    PMA / PMN Number
    P190025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN ELEVATED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A QUALITY DATA REVIEW AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: QUALITY DATA REVIEW NONCONFORMANCE (NC) / CORRECTIVE AND PREVENTIVE ACTION (CAPA) SEARCH A SEARCH OF NC/CAPA RECORDS WAS PERFORMED FOR INSTANCES RELATED TO AN INJURY SUSTAINED WHILE PICKING UP DEBRIS/DUST OFF THE FLOOR BY AN ALINITY M SYSTEM, LN 08N53-02, AS DOCUMENTED IN COMPLAINT TICKET UNDER REVIEW IN THIS INVESTIGATION. THE QUERY DID NOT FIND ANY QUALITY RECORDS, FROM THE LAST 2 YEARS PREVIOUS TO THE COMPLAINT ENTERED DATE, RELATED TO AN INJURY SUSTAINED WHILE PICKING UP DEBRIS/DUST OFF THE FLOOR BY AN ALINITY M SYSTEM. A REVIEW OF CURRENT LABELING CONCLUDED THE OPERATIONS MANUAL AND SERVICE MANUAL PROVIDE SUFFICIENT INFORMATION TO ADDRESS THE ISSUE UNDER REVIEW IN THIS COMPLAINT INVESTIGATION. COMPLAINT HISTORY REVIEW A COMPLAINT SEARCH WAS PERFORMED TO IDENTIFY PAST COMPLAINT TICKETS FOR ANY INSTANCES OF AN INJURY SUSTAINED WHILE PICKING UP DEBRIS/DUST OFF THE FLOOR BY AN ALINITY M SYSTEM, LN 08N53-02. THE COMPLAINT HISTORY REVIEW FOUND THE COMPLAINT TICKET CURRENTLY UNDER INVESTIGATION IS THE SOLE COMPLAINT TICKET RELATED TO INSTANCES OF AN INJURY SUSTAINED WHILE PICKING UP DEBRIS/DUST OFF THE FLOOR BY AN ALINITY M SYSTEM, WITHIN THE LAST 2 YEARS OF THE COMPLAINT TICKET ENTERED DATE. BASED ON THE RESULTS OF THE INVESTIGATION, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THE ALINITY M SYSTEM, LN 08N53-02.

    Additional Manufacturer Narrative · 0

    H1 CORRECTED TO INDICATE TYPE OF REPORT AS SERIOUS INJURY, WHICH IS CONSISTENT WITH THE INITIAL REPORT.

    Description of Event or Problem · 0

    WHILE PERFORMING A PREVENTATIVE MAINTENANCE ON THE ALINITY M INSTRUMENT, THE FIELD SERVICE ENGINEER (FSE) EXPERIENCED A FINGER PRICK. THE FINGER PRICK OCCURRED WITH A GLOVED HAND WHILE PICKING UP DEBRIS/DUST WITH A PAPER TISSUE OFF THE FLOOR BY ALINITY M INSTRUMENT LEG. FINGER PRICK WAS WASHED WITH HAND SOAP, DISINFECTED, AND THE FSE SEEKED MEDICAL ATTENTION AT AN EMERGENCY ROOM (ER). THE INJURY WAS MINOR BUT ENOUGH TO CAUSE SLIGHT BLEEDING. SOME SMALL PIECES OF GLASS OR SHARDS OF PLASTIC WERE SEEN WHERE THE DUST WAS. BUT IT IS NOT CONFIRMED WHAT EXACTLY CAUSED THE PRICK. GLASS/PLASTIC OF THAT THINNESS IS NOT USED NEAR THE INSTRUMENT, SO THE SOURCE OF THE MATERIAL IS UNKNOWN. THE FSE WENT TO THE ER ON (B)(6) 2022. WHILE ON SITE, THEY ADMINISTERED A TETANUS SHOT AS WELL AS BLOOD DRAWS TESTING FOR (B)(6). ALL TESTS CAME BACK AS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212003 ALINITY M SYSTEM REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM OOI ABBOTT MOLECULAR, INC. 08N53-002 00884999048034

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention