BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFINION 2

    MDR report key: 21881228 · Received April 22, 2025

    Report

    Report Number
    9613069-2025-00003
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    April 4, 2025
    Report Date
    July 30, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    UDI-DI
    07070060014418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT IS FOR SIMILAR PRODUCT SOLD IN USA, THE UDI PROVIDED IN SECTION D4 IS THE ACTUAL PRODUCT AND NOT USA VARIANT OF DEVICE. ON (B)(6) 2025. THE ABBOTT REPRESENTATIVE ALSO CONFIRMED THAT THE FOLLOWING FOLLOW-UP ACTIONS HAD BEEN CARRIED OUT BY THE DISTRIBUTOR: - DISTRIBUTOR HAD RETRIEVED THE INSTRUMENT FROM THE END-USER AND TESTED IT FOR OVER TWO HOURS BUT DID NOT ENCOUNTER ANY ISSUES. - PROVIDED A REPLACEMENT INSTRUMENT AS THE END-USER REPORTED SMOKE AND A BURNING SMELL COMING ON (B)(6) 2025, TS INITIATED A RETURN REQUEST, FOR THE AFINION 2 TO BE RETURNED TO THE LEGAL MANUFACTURER, ABBOTT DIAGNOSTICS TECHNOLOGIES AS.

    Additional Manufacturer Narrative · 0

    THE EVENT IS FOR SIMILAR PRODUCT SOLD IN USA, THE UDI PROVIDED IN SECTION D4 IS THE ACTUAL PRODUCT AND NOT USA VARIANT OF DEVICE. ABBOTT REPRESENTATIVE CONFIRMED THAT THE FOLLOWING FOLLOW-UP ACTIONS HAVE BEEN CARRIED OUT BY THE DISTRIBUTOR: DISTRIBUTOR RETRIEVED THE INSTRUMENT FROM THE END-USER AND TESTED IT FOR OVER TWO HOURS BUT DID NOT ENCOUNTER ANY ISSUES. HOWEVER, SINCE THE END-USER REPORTED SMOKE AND A BURNING SMELL COMING FROM THE INSTRUMENT, A REPLACEMENT WAS PROVIDED AS A PRECAUTION. THIS ACTION WAS ALSO COMMUNICATED TO THE SUB-DEALER. THE USER MANUAL EXPLAINS TO PLACE YOUR AFINION 2 ANALYZER ON A DRY, CLEAN, STABLE AND HORIZONTAL SURFACE. MAKE SURE THAT THE ANALYZER IS LOCATED WITH SUFFICIENT SURROUNDING AIRSPACE, AT LEAST 10 CM ON EACH SIDE. PLACEMENT OF AFINION 2 ANALYZER SHOULD ALLOW EASY DISCONNECTION FROM THE WALL OUTLET AT ANY TIME. ACCLIMATE THE ANALYZER TO AMBIENT OPERATING TEMPERATURE (15-32°C, 59-89°F) BEFORE USE. THE ANALYZER MIGHT BE IMPAIRED BY: ¿ CONDENSING HUMIDITY AND WATER. ¿ HEAT AND LARGE TEMPERATURE VARIATIONS. ¿ DIRECT SUNLIGHT. ¿ VIBRATIONS (E.G. FROM CENTRIFUGES AND DISHWASHERS). ¿ ELECTROMAGNETIC RADIATION. ¿ MOVEMENT OF THE ANALYZER DURING PROCESSING OF A TEST CARTRIDGE. THE COMPLAINT DETAILS WERE REVIEWED ALONG WITH OUR INTERNAL RECORDS. THE INTERNAL INVESTIGATION CONCLUDED THAT THE SMOKE AND BURNING ODOR REPORTED IN CONNECTION WITH THE INSTRUMENT WERE ATTRIBUTABLE TO A DEFORMED LID MOTOR BRACKET. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED IN THE COMPLAINT. CUSTOMER COMPLAINTS WILL CONTINUE TO BE MONITORED TO ENSURE CONTROL LIMITS ARE NOT EXCEEDED AND ENSURE PRODUCT'S PERFORMANCE MEETS CUSTOMERS' EXPECTATIONS. THANK YOU FOR TAKING THE TIME TO BRING THIS EVENT TO OUR ATTENTION. IF WE CAN PROVIDE ANY FURTHER ASSISTANCE, PLEASE DO NOT HESITATE TO CONTACT US.

    Description of Event or Problem · 0

    ON (B)(6) 2025 AN END-USER IN SOUTH KOREA PHONED TECHNICAL SERVICES (TS) TO REPORT THAT SMOKE AND A BURNING SMELL WAS COMING FROM AN AFINION 2 INSTRUMENT (SN NOT PROVIDED). THE END-USER TURNED OFF THE INSTRUMENT FOR THE SAFETY ISSUE AND WERE ADVISED BY TS NOT TO SWITCH ON AGAIN. TS CONFIRMED WITH THE END USER THAT THERE WAS NO INJURIES OR HARM. NO PATIENT INVOLVED AND NO IMPACT TO PATIENT. ON (B)(6) 2025 THE ABBOTT REPRESENTATIVE CALLED TS AND PROVIDED THE SERIAL NUMBER OF THE AFINION 2 INSTRUMENT (SN: (B)(6)).

    Description of Event or Problem · 0

    ON (B)(6) 2025 AN END-USER IN SOUTH KOREA PHONED TECHNICAL SERVICES (TS) TO REPORT THAT SMOKE AND A BURNING SMELL WAS COMING FROM AN AFINION 2 INSTRUMENT (SN NOT PROVIDED). THE END-USER TURNED OFF THE INSTRUMENT FOR THE SAFETY ISSUE AND WERE ADVISED BY TS NOT TO SWITCH ON AGAIN. TS CONFIRMED WITH THE END USER THAT THERE WAS NO INJURIES OR HARM. NO PATIENT INVOLVED AND NO IMPACT TO PATIENT. ON 10 APRIL 2025 THE ABBOTT REPRESENTATIVE CALLED TS AND PROVIDED THE SERIAL NUMBER OF THE AFINION 2 INSTRUMENT (SN: (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741847 AFINION 2 ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1116770 10218683 07070060014418

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown