BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFINION AS100 ANALYZER US VERSION RFB

    MDR report key: 23715128 · Received December 4, 2025

    Report

    Report Number
    9613069-2025-00005
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 8, 2025
    Report Date
    February 3, 2026
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    UDI-DI
    07070060008042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DATE HAS BEEN SET AT 08 NOV 2025, HOWEVER THE ISSUE HAPPENED OVER THE WEEKEND AND THE EXACT DATE HAS NOT BEEN PROVIDED. MULTIPLE ATTEMPTS TO OBTAIN THE EVENT DATE HAVE BEEN MADE, THEY HAVE BEEN UNSUCCESSFUL. RETURN OF AS100 ANALYZER AND REPLACEMENT WITH AFINION ANALYZER (CURRENT MODEL) HAS BEEN COMPLETED. THE COMPLAINT DETAILS WERE REVIEWED ALONG WITH INTERNAL RECORDS. THE AFINION PRODUCTS WERE RETURNED AND INSPECTED, WHICH CONCLUDED THAT THE EVENT OF THE POTENTIAL ELECTRICAL SHOCK WAS DUE TO A FAILURE WITH THE POWER SUPPLY, CONNECTED WITH THE ALERE AFINION AS100 ANALYZER. THERE WERE NO FAULTS IDENTIFIED WITH THE INSTRUMENT ITSELF. THE OVERALL INSPECTION ON THE PERFORMANCE OF THE PRODUCT PASSED. IT IS IMPORTANT TO ENSURE THAT THE ALERE AFINION AS100 ANALYZER IS PLACED ON A DRY, CLEAN, STABLE AND HORIZONTAL SURFACE. MAKE SURE THAT THE ANALYZER IS LOCATED WITH SUFFICIENT SURROUNDING AIRSPACE, AT LEAST 5 INCHES ON EACH SIDE. ACCLIMATE THE ANALYZER TO AMBIENT OPERATING TEMPERATURE (15-32°C, 59-89°F).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, USE OF THIS INSTRUMENT IN A DRY ENVIRONMENT, ESPECIALLY IF SYNTHETIC MATERIALS ARE PRESENT (SYNTHETIC CLOTHING, CARPETS ETC.) MAY CAUSE ELECTROSTATIC DISCHARGE. CONNECT THE POWER CABLE TO THE POWER CORD ADAPTER. INSERT THE PLUG FROM THE POWER CORD ADAPTER INTO THE POWER SOCKET IN THE BACK OF THE ANALYZER. PLUG IN THE POWER CORD TO A WALL OUTLET.

    Additional Manufacturer Narrative · 0

    THE EVENT DATE HAS BEEN SET AT 08 NOV 2025, HOWEVER THE ISSUE HAPPENED OVER THE WEEKEND AND THE EXACT DATE HAS NOT BEEN PROVIDED. MULTIPLE ATTEMPTS TO OBTAIN THE EVENT DATE HAVE BEEN MADE, THEY HAVE BEEN UNSUCCESSFUL. RETURN AND REPLACEMENT INITIATED. CUSTOMER INITIATED RETURN OF AS100 ANALYZER ON 13 NOV 2025, AND IS NOT YET RECEIVED BY THE MANUFACTURER.

    Description of Event or Problem · 0

    ON (B)(6) 2025: CUSTOMER PHONED TECHNICAL SERVICES (TS) INFORMING THAT ONE OF THEIR PROVIDERS EMAILED ABOUT AFINION INSTRUMENT, (SN (B)(6), MAKING A LOUD NOISE UPON START UP, THEY TRIED UNPLUGGING AND PLUGGING IT BACK IN BUT THE RED LIGHT WAS BLINKING, THE SCREEN THEN DISPLAYED A SELF-TEST ERROR, THE ANALYZER WAS IN A NONE-OPERATIVE MODE. THE CUSTOMER ALSO REPORTED THAT ONE OF THE PROVIDERS ALSO INFORMED THAT IT ALMOST SHOCKED THEM, PROBABLY WHEN THEY ARE UNPLUGGING/PLUGGING IT. THIS ONLY HAPPENED WITH 1 PROVIDER, AS WHAT THE CUSTOMER RECALLED. CUSTOMER LATER CLARIFIED THAT ELECTRICAL SHOCK WAS FROM THE POWER SUPPLY AND THEY TOUCHED THE MACHINE AND DID NOT EXPERIENCE ANY ELECTRICAL SHOCK. IT WAS ALSO CONFIRMED THAT THERE ARE NO SPARKS, NO SMOKE, AND NO BURNING IN THE MACHINE. A MASCOT (BLACK AND BLUE) POWER SUPPLY WAS USED (SERIAL NUMBER/DATE CODE NOT PROVIDED), WITH THE MAINS CORD PLUGGED TO A MAIN OUTLET. THE CIRCUIT BREAKER DID NOT TRIP. NO OTHER INSTANCES OF STATIC ELECTRICITY HAD BEEN EXPERIENCED. THE INSTRUMENT WAS PLACED IN A DRY ENVIRONMENT.

    Description of Event or Problem · 0

    10NOV2025: CUSTOMER PHONED TECHNICAL SERVICES (TS) INFORMING THAT ONE OF THEIR PROVIDERS EMAILED ABOUT AFINION INSTRUMENT, (SN: (B)(6), MAKING A LOUD NOISE UPON START UP, THEY TRIED UNPLUGGING AND PLUGGING IT BACK IN BUT THE RED LIGHT WAS BLINKING, THE SCREEN THEN DISPLAYED A SELF-TEST ERROR, THE ANALYZER WAS IN A NONE-OPERATIVE MODE. THE CUSTOMER ALSO REPORTED THAT ONE OF THE PROVIDERS ALSO INFORMED THAT IT ALMOST SHOCKED THEM, PROBABLY WHEN THEY ARE UNPLUGGING/PLUGGING IT. THIS ONLY HAPPENED WITH 1 PROVIDER, AS WHAT THE CUSTOMER RECALLED. CUSTOMER LATER CLARIFIED THAT ELECTRICAL SHOCK WAS FROM THE POWER SUPPLY AND THEY TOUCHED THE MACHINE AND DID NOT EXPERIENCE ANY ELECTRICAL SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979231 AFINION AS100 ANALYZER US VERSION RFB ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1115390 10218473 07070060008042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown