BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFINION 2

    MDR report key: 11063205 · Received December 23, 2020

    Report

    Report Number
    3003045237-2020-00010
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    December 15, 2020
    Report Date
    December 23, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    PMA / PMN Number
    K182988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMPLOYEE REPORTED THAT WHEN THE INCIDENT HAPPENED THE POWER SUPPLY WAS CONNECTED TO THE WALL OUTLET BEFORE CONNECTING TO THE INSTRUMENT. THE USER MANUAL FOR THE INSTRUMENT INSTRUCTS THE USER TO CONNECT IN THE FOLLOWING ORDER: CONNECT THE POWER CABLE TO THE POWER CORD ADAPTER. INSERT THE PLUG FROM THE POWER CORD ADAPTER INTO THE POWER SOCKET IN THE BACK OF THE ANALYZER. PLUG THE POWER CORD TO WALL A OUTLET. THE ANALYZER IS IN TRANSIT TO THE MANUFACTURER AND FURTHER INVESTIGATION WILL BE PERFORMED WHEN THE ANALYZER HAS BEEN RETURNED.

    Description of Event or Problem · 1

    AN ABBOTT EMPLOYEE REPORTED THAT THE ANALYZER DID NOT STAY POWERED ON. THE ANALYZER STARTED THE SELF TEST AND THEN SHUT OFF. THE EMPLOYEE DISCONNECTED AND RECONNECTED THE ANALYZER. WHEN CONNECTING THE POWER SUPPLY TO THE ANALYZER, SPARK WAS OBSERVED FROM THE BACK OF THE ANALYZER, IN THE PLUG-IN PORT, AND THERE WAS A BURNT SMELL. THE BLUE LIGHT IN THE POWER SUPPLY WAS ILLUMINATED. THE POWER SUPPLY WAS CONNECTED TO THE WALL OUTLET WHEN BEING RECONNECTED TO THE INSTRUMENT. THE EMPLOYEE REPORTED SHE WAS NOT HURT. THERE WAS NO INJURY AND NO EVIDENCE OF FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533882 AFINION 2 ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1116554

    Patients

    Seq Age Sex Outcome Treatment
    1