BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 23114824 · Received September 22, 2025

    Report

    Report Number
    3016438761-2025-00545
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    September 8, 2025
    Report Date
    September 22, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INSTALLATION OF ALINITY I PROCESSING MODULE SERIAL NUMBER (B)(6), THE FIELD SERVICE REPRESENTATIVE (FSR) OBSERVED MESSAGE CODES 5820, 2529, 5007, 2531 AND INSPECTED THE MODULE. THE FSR DETERMINED THE PCB, PIPETTOR CONTROL BOARD ((B)(6) LOT # GM71002132) FAILED UPON FIRST USE AND WAS REPLACED. WHEN REMOVING THE PCB, THE FSR OBSERVED CHARRED PARTS. REPLACEMENT OF THE PCB, PIPETTOR CONTROL BOARD RESOLVED THE ISSUES AND INSTALLATION PROCEDURES WERE SUCCESSFULLY COMPLETED. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL TICKETS ASSOCIATED WITH CHARRED PARTS OR SMOKE. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ALINITY I PROCESSING MODULE DID NOT IDENTIFY ANY SIMILAR ISSUES ASSOCIATED WITH CHARRED PARTS OR SMOKE AS DESCRIBED IN THIS COMPLAINT. ADDITIONALLY REVIEW OF COMPLAINT AND TRENDING DATA ASSOCIATED WITH THE PCB, PIPETTOR CONTROL BOARD DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS FOR THE PCB, PIPETTOR CONTROL BOARD (A-90000135-02) AND THE ALINITY I PROCESSING MODULE, SERIAL (B)(6). THE 2025 UL CERTIFICATION MEMO INDICATES THAT ABBOTT DIAGNOSTIC EQUIPMENT AND ACCESSORIES ARE CERTIFIED TO THE APPROPRIATE SAFETY STANDARDS, AND ADEQUATE PROTECTION IS PROVIDED FOR THE OPERATOR AGAINST SPREAD OF FIRE FROM THE EQUIPMENT. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I PROCESSING MODULE FOR SERIAL (B)(6) OR THE PCB, PIPETTOR CONTROL BOARD WAS IDENTIFIED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE FIELD SERVICE REPRESENTATIVE (FSR) WAS ONSITE PERFORMING THE CONTINUED INSTALLATION OF THE ALINITY I PROCESSING MODULE. DURING THE PROCESS, THE FSR ENCOUNTERED MULTIPLE INSTRUMENT ERROR MESSAGES. THE ERRORS INCLUDED: ¿ (B)(6) - REAGENT CARTRIDGE UNLOADING ERROR AT REAGENT CAROUSEL POSITION (X). ¿ (B)(6) ¿ PIPETTING ARM CALIBRATION ERROR (R1). ¿ (B)(6) ¿ SERVO CONTROLLER ERROR (R1 THETA). ¿ (B)(6) ¿ PIPETTING ARM (R1) GROUND CALIBRATION ERROR. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND FOUND THAT THE PIPETTOR CONTROL BOARD (PCB) WAS DAMAGED AND REQUESTED A REPLACEMENT. WHILE REMOVING THE DAMAGED PCB, THE FSR OBSERVED CHARRED INTEGRATED CIRCUITS AND CAPACITORS ACROSS MULTIPLE COMPONENTS. AFTER INSTALLING THE NEW PCB, ALL REQUIRED INSTALLATION VERIFICATIONS WERE SUCCESSFULLY COMPLETED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510225 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PCB, PIPETTOR CONTROL BOARD, (B)(6), GM7100.