BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFINION 2

    MDR report key: 10099953 · Received May 29, 2020

    Report

    Report Number
    3003045237-2020-00005
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    April 16, 2020
    Report Date
    May 29, 2020
    Manufacturer
    ABBOTT DIAGNOSITCS TECHNOLOGIES AS
    Product Code
    JQT
    PMA / PMN Number
    K171650
    Removal / Correction Number
    9613069-02/03/2020-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINTS HAVE BEEN RECEIVED REGARDING ELECTROSTATIC DISCHARGE (ESD) AND/OR POWER SUPPLY FAILURE FOR AFINION 2 AND ALERE AFINION AS100 ANALYZER. AN INVESTIGATION HAS CONCLUDED THAT THE ROOT CAUSE FOR THE OBSERVED LEVEL OF COMPLAINTS RELATED TO ESD EVENTS AND POWER SUPPLY FAILURE IS ASSOCIATED WITH THE POWER SUPPLY NOT WITHSTANDING BUILD-UP OF ELECTROSTATIC DISCHARGE IN THE USE ENVIRONMENT BASED ON THE DESIGN AND CONSTRUCTION OF THE POWER SUPPLY. AN 806 FOR ALERE AFINION AS100 ANALYZER AND AFINION 2 WAS SENT TO THE FDA ON 3 FEBRUARY 2020 FOR A CORRECTION OF THE POWER SUPPLY PROVIDED WITH THE ANALYZERS BY REPLACING THE CURRENT POWER SUPPLY WITH A NEW POWER SUPPLY CERTIFIED TO A HIGHER STANDARD. ADDITIONALLY AN UPDATE TO THE USER MANUALS FOR THE ANLAYZERS WAS MADE TO PROVIDE AWARENESS TO THE RISK OF ELECTROSTATIC DISCHARGE EVENTS. MANUFACTURER'S REFERENCE FOR THE 806 IS 9613069-02/03/2020-001-C (REFERENCE ASSIGNED BY FDA: (B)(4)).

    Description of Event or Problem · 1

    THE CUSTOMER PLUGGED IN THE INSTRUMENT TO THE WALL SOCKET. THE CUSTOMER THEN NOTICED A SMALL FLASH AND HEARD A SOUND OF A SMALL ELECTRIC SHOCK AND SMELLED SMOKE. THE CUSTOMER NOTICED THE SMALL FLASH IN THE SOCKET AREA. SHE DESCRIBED IT AS SOMETHING AS STATIC SHOCK. SHE ALSO REPORTED THAT SHE "WAS PRETTY SURE" SHE SMELLED SOME MINOR SMOKE IN THE ROOM RIGHT AFTER THE INCIDENT THE CUSTOMER ALSO STATED THAT SHE TRIED TO START THE INSTRUMENT AFTER THE INCIDENT USING DIFFERENT CORDS AND POWER SOCKETS BUT THE INSTRUMENT DID NOT POWER ON AT ALL. THERE WAS NO INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567453 AFINION 2 ANALYZER JQT ABBOTT DIAGNOSITCS TECHNOLOGIES AS 1116553

    Patients

    Seq Age Sex Outcome Treatment
    1