BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 20817987 · Received December 2, 2024

    Report

    Report Number
    3016438761-2024-00688
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 22, 2024
    Report Date
    January 27, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND OBSERVED THAT THE ALNTY C PWR CN EU WAS CHARRED. THE PART WAS REPLACED WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ISSUES OF CHARRING RELATED TO THE ALNTY C PWR CN EU REPORTED FOR (B)(6). A REVIEW OF TRACKING AND TRENDING OF THE ALINITY I DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ALNTY C PWR CN EU DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. 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. THE CHARRING OBSERVED WAS LIMITED TO ALNTY C PWR CN EU; THE CHARRING DID NOT SPREAD TO OTHER PARTS OF THE MODULE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I PROCESSING MODULE FOR SERIAL (B)(6) OR THE ALNTY C PWR CN EU WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE ALINITY I PROCESSING MODULE STOPPED RUNNING. UPON INSPECTION, THE CUSTOMER FOUND THE ELECTRICAL OUTLET WAS OXIDIZED AND HEARD A SIZZLING SOUND. THE INSTRUMENT WAS UNPLUGGED, AND THE PLUG WAS HOT TO THE TOUCH. UPON INSPECTION THE ELECTRICAL CONNECTOR OF THE POWER CABLE WAS FOUND TO CHARRED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO HARM TO THE USER WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE ALINITY I PROCESSING MODULE STOPPED RUNNING. UPON INSPECTION, THE CUSTOMER FOUND THE ELECTRICAL OUTLET WAS OXIDIZED AND HEARD A SIZZLING SOUND. THE INSTRUMENT WAS UNPLUGGED, AND THE PLUG WAS HOT TO THE TOUCH. UPON INSPECTION THE ELECTRICAL CONNECTOR OF THE POWER CABLE WAS FOUND TO CHARRED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO HARM TO THE USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93778 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown