BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFINION 2

    MDR report key: 10807598 · Received November 9, 2020

    Report

    Report Number
    3003045237-2020-00007
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Date of Event
    October 14, 2020
    Report Date
    November 5, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    PMA / PMN Number
    K182988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELDS LEFT OPEN ARE EITHER NOT AVAILABLE OR NOT RELEVANT. RETURN OF INSTRUMENT HAS BEEN REQUESTED FROM THE CUSTOMER AND INVESTIGATION IS PLANNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ANALYZER AFINION 2 DID NOT TURN ON AND THAT THE CABLE WAS DAMAGED. THERE WAS NO CHARRING OR SMOKING AND NO INJURY WAS REPORTED. THE ANALYZER SHUTS OFF WHEN THE CABLE IS TOUCHED OR THE ANALYZER IS MOVED. SOMETIMES SPARKS HAVE BEEN OBSERVED WHEN THEY MOVE THE CABLE CONNECTED TO THE SIDE OF THE WALL PLUG. THE CUSTOMER CONFIRMED THAT THE SAME ISSUE HAS BEEN OBSERVED WITH OTHER EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272052 AFINION 2 ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1116679 10203079

    Patients

    Seq Age Sex Outcome Treatment
    1