BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY M SYSTEM

    MDR report key: 22906003 · Received August 27, 2025

    Report

    Report Number
    3005248192-2025-00296
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    August 24, 2025
    Report Date
    October 3, 2025
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    OOI
    UDI-DI
    00884999048034
    PMA / PMN Number
    P190025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A NONCONFORMANCE (NC)/CAPA HISTORY REVIEW, EXISTING DATA REVIEW, INSTRUMENT ANALYSIS, AND A COMPLAINT HISTORY REVIEW. THE INVESTIGATION IS AS FOLLOWS: CAPA / NON-CONFORMANCE REVIEW: A SEARCH OF NC/CAPA RECORDS WAS PERFORMED FOR ANY INSTANCES OF AN INJURY SUSTAINED FROM THE WASTE EXTRACTION NOZZLES ON AN ALINITY M SYSTEM. THE QUERY DID NOT IDENTIFY ANY QUALITY RECORDS RELATED TO AN INJURY SUSTAINED ON THE WASTE EXTRACTION NOZZLES ON AN ALINITY M SYSTEM, LN 08N53-002. EXISTING DATA REVIEW: A REVIEW OF CURRENT LABELING/WARNINGS/HAZARDS IN THE ALINITY M OPERATIONS MANUAL WERE REVIEWED. THE PRODUCT LABELING PROVIDES INFORMATION REGARDING SAFETY SYMBOLS, BIOLOGICAL HAZARDS, SHARPS, PERSONAL SAFETY, PROPER CLEANING OF INSTRUMENT, AND COMPLIES WITH APPLICABLE SAFETY STANDARDS REGARDING SHARP EDGES, INCLUDING IEC 61010-1 SAFETY STANDARD, SECTION 7. PER THE APPLICABLE SECTIONS OF IEC 61010-1 SAFETY STANDARD, SECTION 7 CONTAINS GENERAL REQUIREMENTS FOR SHARP EDGES: ALL EASILY TOUCHED PARTS OF THE EQUIPMENT SHALL BE SMOOTH AND ROUNDED SO AS NOT TO CAUSE INJURY DURING NORMAL USE. INSTRUMENT ANALYSIS: A VISUAL AND PHYSICAL INSPECTION OF THREE (3) INSTRUMENTS IN HOUSE AT ABBOTT MOLECULAR, LOCATED IN DES PLAINES, IL, REVEALED NO VISIBLE SHARP EDGES ON THE WASTE EXTRACTION NOZZLES. A PHYSICAL INSPECTION WAS CONDUCTED BY PHYSICALLY EXAMINING THE NOZZLES. PER INSPECTION, THERE WERE NO RIGID OR SHARP EDGES FOUND ON THE WASTE EXTRACTION NOZZLES. PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS WORN WHILE IN CONTACT WITH THE WASTE EXTRACTION NOZZLES AND THE ALINITY M INSTRUMENT. THE OVERALL PRODUCT AS DESIGNED, PER SAFETY STANDARD IEC/EN 61010-1, CONTINUES TO MEET SAFETY STANDARDS REGARDING SHARP EDGES. COMPLAINT HISTORY REVIEW: A COMPLAINT SEARCH WAS PERFORMED TO IDENTIFY PAST COMPLAINT TICKETS RELATED TO AN INJURY SUSTAINED FROM THE WASTE EXTRACTION NOZZLES ON AN ALINITY M SYSTEM LN 08N53-002. THE COMPLAINT HISTORY REVIEW SHOWED THAT IN THE TWO YEARS PRIOR TO THE ENTERED (ORIGINATION) DATE OF THE COMPLAINT TICKET UNDER INVESTIGATION, NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. COMPLAINT TRENDING WAS REVIEWED. AN ADVERSE TREND WAS NOT 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 08N53-002.

    Description of Event or Problem · 0

    A FIELD SERVICE ENGINEER (FSE) REPORTED AN INJURY ON AN ALINITY M SYSTEM. THE FSE WAS INJURED WHILE ATTEMPTING TO ACCESS SOME COMPONENTS IN THE WASTE EXTRACT UNIVERSAL BOARD. THE FSE RECEIVED A BRUISE/SMALL CUT ON THE SKIN OF THE FRONT HEAD CAUSED BY ONE OF THE WASTE NOZZLES. THE INCIDENT OCCURRED ON A SUNDAY ((B)(6) 2025), WHEN THE HOSPITAL PHARMACY IN THE ART (ANTIRETROVIRAL THERAPY) CLINIC WAS CLOSED. HOWEVER, THE FSE WAS GIVEN FIRST AID TREATMENT IN THE LABORATORY ON THE DAY OF OCCURRENCE. ON (B)(6) 2025, THE FSE WAS TESTED FOR HIV AT THE ART CLINIC. THE RESULT WAS NEGATIVE. THE FSE RECEIVED 28 DAYS OF PEP (POST-EXPOSURE PROPHYLAXIS) TREATMENT AND STARTED IT. AN HIV CHECK-UP TEST IS PLANNED IN 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108555 ALINITY M SYSTEM REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM OOI ABBOTT MOLECULAR, INC. 00884999048034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention