BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE AFINION AS100 ANALYZER

    MDR report key: 22726456 · Received August 6, 2025

    Report

    Report Number
    9613069-2025-00004
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 28, 2025
    Report Date
    November 12, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT IS RELATED TO SAME / SIMILAR DEVICE IN THE US UNDER PRODUCT NUMBER: 1115175 AND PRIMARY UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    EVENT IS RELATED TO SAME / SIMILAR DEVICE IN THE US UNDER PRODUCT NUMBER: 1115175 AND PRIMARY UDI: (B)(4). THE COMPLAINT DETAILS WERE REVIEWED ALONG WITH OUR 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. THERE IS NO INDICATION THAT THE REPORTED ISSUES IS RELATED TO PRODUCT RESULTS, INADEQUATE INSTRUCTIONS FOR USE OR INACCURATE LABELING. FINDINGS FROM INTERNAL INVESTIGATION COULD NOT CONFIRM ISSUES RELATED TO SPARK ON THE ANALYZER ITSELF. HOWEVER, THE SELF-TEST ERROR COULD BE REPRODUCED INTERNALLY, AND IT APPEARS TO BE LINKED TO A SLOW FLIP-LID MECHANISM. THE SELF-TEST VALIDATES HARDWARE AND SOFTWARE INTEGRITY, TEST CARTRIDGE TRANSPORT SYSTEM, LIQUID TRANSPORT SYSTEM, AND THE CAMERA VISION SYSTEM. WHEN THE ANALYZER IS POWERED ON FOR A LONGER PERIOD, IT WILL AUTOMATICALLY RESTART ONCE A DAY TO ENSURE THAT THE SELF-TEST IS DONE REGULARLY. USERS MAY RECEIVE A MESSAGE, ¿SELF-TEST ERROR; ANALYZER IN NON-OPERATIVE MODE¿. FAILURE TO COMPLETE THE SELF-TEST CAN BE CAUSED BY A VARIETY OF POTENTIAL ROOT CAUSES AND IF THE ISSUE PERSISTS THE ANALYZER NEEDS TO BE RETURNED AND REPLACED. CUSTOMER COMPLAINTS WILL CONTINUE TO BE MONITORED TO ENSURE CONTROL LIMITS ARE NOT EXCEEDED AND ENSURE THAT PRODUCT PERFORMANCE MEETS CUSTOMER EXPECTATIONS.

    Description of Event or Problem · 0

    ON 28-JUL-2025 A CUSTOMER REPORTED TO HAVE AN ISSUE WITH THEIR AFINION AS100 ANALYZER AFTER THEY PERFORMED THE CLEANING. TECHNICAL SERVICES CONTACTED THE CUSTOMER BY PHONE, WHO REPORTED THAT AFTER THEY CONNECTED THEIR AFINION AS100 ANALYZER TO THE POWER OUTLET AFTER CLEANING THE INSTRUMENT, IT DISPLAYED A SELF-TEST ERROR. THE CUSTOMER THEN PULLED OUT THE POWER SUPPLY AGAIN AND SHORTLY BEFORE PLUGGING IN THE POWER CABLE INTO THE WALL AGAIN IT SPARKED. ON THE SAME DATE THE CUSTOMER ALSO CONFIRMED: - ONLY THE USER OF THE INSTRUMENT WAS INVOLVED AND NOT IMPACTED. - THE SPARK CAME FROM THE POWER SUPPLY AND THE CIRCUIT BREAKER DID NOT TRIP. - THE USER DID NOT ATTEMPT TO USE THE INSTRUMENT AFTER THE ISSUE OCCURRED. - THE ANALYZER IS PLACED WITH SUFFICIENT SURROUNDING AIRSPACE (AT LEAST 10 CM ON EACH SIDE), AS PER THE USER MANUAL. - NO OTHER OBSERVATIONS WERE MADE BY THE CUSTOMER.

    Description of Event or Problem · 0

    ON 28-JUL-2025 A CUSTOMER REPORTED TO HAVE AN ISSUE WITH THEIR AFINION AS100 ANALYZER AFTER THEY PERFORMED THE CLEANING. TECHNICAL SERVICES CONTACTED THE CUSTOMER BY PHONE, WHO REPORTED THAT AFTER THEY CONNECTED THEIR AFINION AS100 ANALYZER TO THE POWER OUTLET AFTER CLEANING THE INSTRUMENT, IT DISPLAYED A SELF-TEST ERROR. THE CUSTOMER THEN PULLED OUT THE POWER SUPPLY AGAIN AND SHORTLY BEFORE PLUGGING IN THE POWER CABLE INTO THE WALL AGAIN IT SPARKED. ON THE SAME DATE THE CUSTOMER ALSO CONFIRMED: - ONLY THE USER OF THE INSTRUMENT WAS INVOLVED AND NOT IMPACTED. - THE SPARK CAME FROM THE POWER SUPPLY AND THE CIRCUIT BREAKER DID NOT TRIP. - THE USER DID NOT ATTEMPT TO USE THE INSTRUMENT AFTER THE ISSUE OCCURRED. - THE ANALYZER IS PLACED WITH SUFFICIENT SURROUNDING AIRSPACE (AT LEAST 10 CM ON EACH SIDE), AS PER THE USER MANUAL. - NO OTHER OBSERVATIONS WERE MADE BY THE CUSTOMER. ON 31-JUL-2025 THE CUSTOMER FURTHER CONFIRMED: - THE SPARK WAS FROM THE POWER SUPPLY. - IT WAS FROM THE MAINS CORD. - THERE WAS NO SHOCK OR ELECTROSTATIC DISCHARGE, ONLY A SPARK. - THE CIRCUIT BREAKER DID NOT TRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365548 ALERE AFINION AS100 ANALYZER ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 10187763 10187763

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown