BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY M SYSTEM

    MDR report key: 23123461 · Received September 23, 2025

    Report

    Report Number
    3005248192-2025-00328
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    August 31, 2025
    Report Date
    November 7, 2025
    Manufacturer
    ABBOTT MOLECULAR, INC
    Product Code
    OOI
    PMA / PMN Number
    P190025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A NONCONFORMANCE (NC)/CAPA HISTORY REVIEW, EXISTING DATA REVIEW, AND A COMPLAINT HISTORY REVIEW. THE INVESTIGATION IS AS FOLLOWS: CAPA/ NON-CONFORMANCE REVIEW: A SEARCH OF NC/CAPA RECORDS WAS PERFORMED IFOR INSTANCES RELATED TO AN INJURY SUSTAINED DURING CLEANING OF THE FLAPPER/WASTE CHUTE WITH THE WASTE CHUTE SHROUD IN PLACE ON ALINITY M SYSTEM. THE NC/CAPA SEARCH DID NOT FIND ANY QUALITY RECORDS RELATED AN INJURY SUSTAINED DURING CLEANING OF THE FLAPPER/WASTE CHUTE WITH THE WASTE CHUTE SHROUD IN PLACE ON AN ALINITY M SYSTEM. EXISTING DATA REVIEW: A REVIEW OF CURRENT LABELING/WARNINGS/HAZARDS IN THE ALINITY M OPERATIONS MANUAL CONCLUDED TO BE SUFFICIENT IN PREVENTING/MITIGATING ANY POTENTIAL HAZARDS/PHYSICAL INJURIES WHILE PERFORMING MAINTENANCE PROCEDURES ON THE ALINITY M SYSTEM. THE WEEKLY MAINTENANCE PROCEDURE INSTRUCTS THE USER ON PROPER CLEANING OF THE WASTE CHUTE AND CAUTIONS THE USER ABOUT BIOLOGICAL RISKS AND INJURY BY MECHANICAL HAZARDS DURING CLEANING AS FOLLOWS: "THE AMPLIFIED WASTE CHUTE AND ITS FLAPPER MAY CONTAIN SHARP EDGES. DO NOT ATTEMPT TO ACCESS ITS INNER WALLS WITH HANDS. IN ADDITION, THE AMPLIFIED WASTE CHUTE MAY CAUSE INJURY OR EXPOSURE TO INFECTIOUS MATERIALS IF DROPPED." COMPLAINT HISTORY REVIEW: A COMPLAINT SEARCH WAS PERFORMED TO IDENTIFY PAST COMPLAINT TICKETS (INCLUDING INJURY COMPLAINTS) RELATED TO AN INJURY SUSTAINED DURING CLEANING OF THE FLAPPER/WASTE CHUTE WITH THE WASTE CHUTE SHROUD IN PLACE ON AN ALINITY M SYSTEM. THE COMPLAINT HISTORY REVIEW SHOWED THAT WITHIN TWO YEARS OF THE COMPLAINT TICKET ENTERED DATE, NO ADDITIONAL RELATED COMPLAINTS WERE IDENTIFIED. COMPLAINT TRENDING WAS REVIEWED. THE UPPER CONTROL LIMIT WAS NOT EXCEEDED, AND NO ADVERSE TREND WAS IDENTIFIED FOR THE ALINITY M SYSTEM LN 08N53-002. 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

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED INTERNATIONALLY USING THE ALINITY M SYSTEM, LIST 08N53-002, WHICH IS ALSO US FDA APPROVED.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED TO REPORT AN INJURY ON AN ALINITY M SYSTEM. THE INCIDENT OCCURRED ON (B)(6) 2025. DURING THE WEEKLY MAINTENANCE, AND WHILE WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) OF LAB COAT AND GLOVES, THE TECHNICIAN ON DUTY SUFFERED A CUT ON THEIR HAND DUE TO THE FLAPPER BORDERS TRAPPING THEIR HAND AGAINST THE WASTE CHUTE SHROUD. THE EXTENT OF THE DAMAGE DID NOT REQUIRE SUTURE POINTS, ONLY CLEANING AND BAND-AID. HOWEVER, DUE TO THE INSTRUMENT BEING USED TO PERFORM THE VIRAL LOAD ASSAYS (HIV, HBV, AND HCV), THE TECHNICIAN HAS BEEN PUT UNDER POST-EXPOSURE PROPHYLAXIS (PEP) FOR HIV, AS WELL AS ANTI-HBV IMMUNOGLOBULIN INFUSION AND A HBV REFRESHER VACCINE, DUE TO THE TECHNICIAN HAVING HBV PROTECTION LEVELS IN BLOOD UNDER THE EXPECTED VALUES. THE PEP TREATMENT WILL HAVE A DURATION OF 28 DAYS FROM THE STARTING DAY. CUSTOMER WILL COMMUNICATE IF FURTHER ISSUES ARISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228360 ALINITY M SYSTEM REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM OOI ABBOTT MOLECULAR, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention