BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFINION 2

    MDR report key: 16202953 · Received January 19, 2023

    Report

    Report Number
    9613069-2023-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 27, 2022
    Report Date
    June 22, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    PMA / PMN Number
    K171650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RISKS ARE EVALUATED TO BE IN THE LOW RISK REGION FOR THE USER/PATIENT. THE RISKS SHOW THAT THE EVENT IS CORRESPONDING WITH WHAT IS ANTICIPATED FOR THE NATURE AND SEVERITY OF THE PRODUCT. THE EVENT DOES NOT REPRESENT ANY NEW OR UNANTICIPATED FAILURE MODE OR HAZARD/HARM COMBINATION. THE CASE DETAILS WERE REVIEWED ALONG WITH INTERNAL RECORDS AND NO NONCONFORMANCES WERE IDENTIFIED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED IN THE COMPLAINT CASE. OUR INVESTIGATION DETERMINED THAT THERE IS NO INDICATION THAT THE REPORTED ISSUE IS RELATED TO PRODUCT RESULTS, INADEQUATE INSTRUCTIONS FOR USE OR INACCURATE LABELING.

    Additional Manufacturer Narrative · 0

    DEVICE REQUESTED, BUT NOT YET RETURNED.

    Description of Event or Problem · 0

    28 DEC 2022: TECHNICAL SERVICE (TS) RECEIVED EMAIL FROM CUSTOMER WHO REPORTED THAT THEY OBTAINED INFORMATION CODE 120 ON THEIR AFINION ANALYZER S/N (B)(6), (SW NOT PROVIDED) AND TURNED BLACK. (B)(6) 2022: CUSTOMER INFORMED TS BY EMAIL THERE HAD BEEN SPARKS FROM THE INSTRUMENT NOT PATIENT OR USER WAS HARMED.

    Description of Event or Problem · 0

    28 DEC 2022: TECHNICAL SERVICE (TS) RECEIVED EMAIL FROM CUSTOMER WHO REPORTED THAT THEY OBTAINED INFORMATION CODE 120 ON THEIR AFINION ANALYZER S/N (B)(4), (SW NOT PROVIDED) AND TURNED BLACK. (B)(6) 2022: CUSTOMER INFORMED TS BY EMAIL THERE HAD BEEN SPARKS FROM THE INSTRUMENT. NOT PATIENT OR USER WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105777 AFINION 2 ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1116778 10218276

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown