BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 12979275 · Received December 10, 2021

    Report

    Report Number
    3016438761-2021-00513
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    November 20, 2021
    Report Date
    December 29, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INSTALLING AN INSTRUMENT, THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE FOUND EVIDENCE OF BURN OF THE CIRCUIT BOARD, TEMP-OPTICS CONTROLLER (LN A-90001090-01. THE CIRCUIT BOARD, TEMP-OPTICS CONTROLLER (LN A-90001090-01 WAS REPLACED AND DETERMINED THE LIKELY CAUSE FOR ISSUE. THERE WAS NO FIRE OR SMOKE WAS SEEN NOR ANY DAMAGE TO THE INSTRUMENT. THERE WAS NO INJURY TO PERSONNEL REPORTED. A REVIEW OF THE SERVICE HISTORY FOR THE ALINITY I PROCESSING MODULE, SERIAL NUMBER (B)(6) NO CONTRIBUTING FACTOR ON OR AROUND THE DATE OF THE EVENT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE ALINITY I PROCESSING MODULE OR THE CIRCUIT BOARD, TEMP-OPTICS CONTROLLER. THE 2021 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 ALINITY I SYSTEM OPERATIONS MANUAL PROVIDES INFORMATION REGARDING ELECTRICAL HAZARDS, AND ELECTRICAL SAFETY FOR THE ALINITY I SYSTEMS. THE I SYSTEM SERVICE AND SUPPORT MANUAL PROVIDES INSTRUCTIONS FOR THE CIRCUIT BOARD, TEMP-OPTICS CONTROLLER. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CIRCUIT BOARD, TEMP-OPTICS CONTROLLER (LN A-90001090-01 OR THE ALINITY I PROCESSING MODULE, SERIAL NUMBER (B)(6) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVEMENT. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) NOTICED EVIDENCE OF FIRE/BURN TEMP/OPTICS BOARD ON ALINITY I PROCESSING MODULE. THE FSR WAS ONSITE FOR A3600 INSTALLATION AND NOTICED ALINITY I PROCESSING MODULE WAS OFF-LINE DUE TO ERROR MESSAGE 5230 BOARD FAILED DURING POST. DURING FURTHER INVESTIGATION FSR DETERMINED BURN PARTS OF TEMP/OPTICS BOARD ON ALINITY I PROCESSING MODULE. THERE WAS NO VISIBLE SMOKE OR SPARK DETECTED. NO INJURY TO USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1872093 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6501 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown