BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE AFINION AS100 ANALYZER

    MDR report key: 14084319 · Received April 12, 2022

    Report

    Report Number
    3003045237-2022-00001
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    March 15, 2022
    Report Date
    May 25, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    PMA / PMN Number
    K180296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT INVESTIGATION IN-PROGRESS. INSTRUMENT AND POWER PACK / SUPPLY REQUESTED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION NOW CLOSED. INSTRUMENT AND POWER PACK / SUPPLY WERE REQUESTED FOR INVESTIGATION, HOWEVER HAVE NOT BEEN RECIEVED. AS INSTRUMENT IS NOT AVAILABLE, ASSIGNABLE CAUSE AS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    REPORTEE WAS TOLD BY ANOTHER EMPLOYEE THAT THE MACHINE SPARKED A FIRE. END USER TOLD THE REPORTEE THEY HAD MOVED THE MACHINE TO ANOTHER PLACE IN THE BUILDING. WHEN THEY PLUGGED THE MACHINE IN IT SPARKED A FIRE, THE EMPLOYEE UNPLUGGED THE MACHINE AND THE FIRE WENT AWAY. POWER SUPPLY WAS NOT DAMAGED. INSTRUMENT WAS AT ROOM TEMPERATURE, THE ENVIRONMENT WAS NOT DRY. NO PATIENT INFORMATION IS AVAILABLE HOWEVER, REPORTEE CONFIRMED THERE WAS A DELAY IN RUNNING AND REPORTING PATIENT SAMPLES FOR HBA1C TESTS, WHICH WERE REQUIRED TO BE TESTED EXTERNALLY. NO INJURIES REPORTED. NO ADVERSE PATIENT OUTCOMES REPORTED.

    Description of Event or Problem · 0

    REPORTEE WAS TOLD BY ANOTHER EMPLOYEE THAT THE MACHINE SPARKED A FIRE. WHEN THEY PLUGGED THE MACHINE IN AT NEW LOCATION IT SPARKED A FIRE, THE EMPLOYEE UNPLUGED THE MACHINE AND THE FIRE WENT AWAY. FOLLOW UP INVESTIGATION ESTABLISHED THE FOLLOWING POINTS: - THE INSTRUMENT WAS PLACED IN A DRY ENVIRONMENTAND THE TEMPERATURE WAS 69°F. THERE WERE NO CHANGES IN ENVIRONMENT BETWEEN THE PLACE THE INSTRUMENT WAS PLACED IN AND THE NEW PLACE IT WAS TRANSFERRED TO. - A PATIENT WAS PRESENT AT THE TIME OF THE MALFUNCTION, RESULTING IN A DELAY TO RUNNING HBA1C TESTS AT TIME, AS TESTS HAD TO BE RUN OUT OF HOUSE. - THE INSTRUMENT DID NOT OVERHEAT, IT GAVE A SPARK WHEN PLUGGED IN. NO INJURIES REPORTED. NO ADVERSE PATIENT OUTOMES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145183 ALERE AFINION AS100 ANALYZER ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1115390 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown