BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISAN LINK PRO SPECIAL STAINING SYSTEM

    MDR report key: 21048523 · Received December 31, 2024

    Report

    Report Number
    3003423869-2024-00084
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    November 25, 2024
    Report Date
    March 17, 2025
    Manufacturer
    AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.
    Product Code
    KPA
    UDI-DI
    05700571108451
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED: B4, G3, G6, H2, H6, H11.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED: B4, B5, G3, G6, H2, H6, H11.

    Additional Manufacturer Narrative · 0

    D4, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: DI DOCUMENTED AS THE IVD CLASS I DEVICE WAS MANUFACTURED IN 2016.

    Description of Event or Problem · 0

    THE UNITED STATES OF AMERICA CUSTOMER REPORTED THE ARTISAN INSTRUMENT'S HEATER PLATES WERE TURNING ON AND STAYING ON EVEN WHEN NOT IN USE, CAUSING THE INSTRUMENT ITSELF TO BE HOT TO THE TOUCH. THE USER ACCIDENTALLY BURNED TWO FINGERS ON THEIR LEFT HAND, THE MIDDLE AND RING FINGERS, WHEN ROTATING THE ARTISAN SLIDE CAROUSEL. THE BURN CAUSED BLISTERS ON THE USER'S FINGERTIPS. THE USER DID NOT SEEK MEDICAL TREATMENT HOWEVER, THE USER DID RUN WATER OVER THEIR FINGERS AND THEN APPLIED ICE. AN INTERNAL INJURY REPORT WAS LOGGED WITH THE USER FACILITY. IT WAS NOTED THE USER HAD LIMITED USE OF THEIR HAND THAT DAY AND WAS NOT ABLE TO SECTION TISSUE BLOCKS ON THE MICROTOME. IT WAS CONFIRMED THE USER DIDN'T SEEK ADDITIONAL MEDICAL INTERVENTION OR TREATMENT SINCE THE TIME OF THE INCIDENT. THE USER IS NO LONGER LIMITED IN THE USER OF THEIR HAND AND THE FINGERS ARE "NEARLY HEALED". THE CUSTOMER NOTES THE USER BURNED THEIR FINGERS ON HEATER POSITION 48 AND POSSIBLY 47. THE AGILENT FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND NOTED, WHEN POWERING ON THE ARTISAN USING THE PHYSICAL SWITCH, HEATERS 25-48 WOULD ACTIVATE. THE FSE REPLACED THE HEATER CONTROL BOARDS UNDERNEATH HEATERS 25-48, AND CONFIRMED THE 48V AND 24V PSU IS WORKING PROPERLY. ADDITIONALLY, HEATER NUMBER 48 WAS REPLACED DUE TO IT BEING HOTTER THAN THE REST. THE REMAINDER OF THE SERVICE HAD TO BE CONTINUED BY A DIFFERENT FSE WHO FOUND THE CAUSE OF THE ISSUE TO BE THE HEATER CONTROL BOARD IN POSITION 3 WHICH CAUSED HEATERS 25-48 HEATERS TO TURN ON AND OVERHEAT. THIS CONTROL BOARD WAS REPLACED FOLLOWING THIS FINDING. ADDITIONALLY, OTHER RELATED COMPONENTS WERE REPLACED PROACTIVELY. THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. TESTING WAS ABLE TO BE COMPLETED USING ANOTHER INSTRUMENT. AFTER FURTHER INVESTIGATION, IT'S BELIEVED THAT REAGENTS LEAKED ONTO THE HEATER CONTROL BOARD CAUSING IT TO SHORT CIRCUIT LEADING TO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE UNITED STATES OF AMERICA CUSTOMER REPORTED THE ARTISAN INSTRUMENT'S HEATER PLATES WERE TURNING ON AND STAYING ON EVEN WHEN NOT IN USE, CAUSING THE INSTRUMENT ITSELF TO BE HOT TO THE TOUCH. THE USER ACCIDENTALLY BURNED TWO FINGERS ON THEIR LEFT HAND, THE MIDDLE AND RING FINGERS, WHEN ROTATING THE ARTISAN SLIDE CAROUSEL. THE BURN CAUSED BLISTERS ON THE USER'S FINGERTIPS. THE USER DID NOT SEEK MEDICAL TREATMENT HOWEVER, THE USER DID RUN WATER OVER THEIR FINGERS AND THEN APPLIED ICE. AN INTERNAL INJURY REPORT WAS LOGGED WITH THE USER FACILITY. IT WAS NOTED THE USER HAD LIMITED USE OF THEIR HAND THAT DAY AND WAS NOT ABLE TO SECTION TISSUE BLOCKS ON THE MICROTOME. IT WAS CONFIRMED THE USER DIDN'T SEEK ADDITIONAL MEDICAL INTERVENTION OR TREATMENT SINCE THE TIME OF THE INCIDENT. THE USER IS NO LONGER LIMITED IN THE USER OF THEIR HAND AND THE FINGERS ARE "NEARLY HEALED". THE CUSTOMER NOTES THE USER BURNED THEIR FINGERS ON HEATER POSITION 48 AND POSSIBLY 47. THE AGILENT FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND NOTED, WHEN POWERING ON THE ARTISAN USING THE PHYSICAL SWITCH, HEATERS 25-48 WOULD ACTIVATE. THE FSE REPLACED THE HEATER CONTROL BOARDS UNDERNEATH HEATERS 25-48, AND CONFIRMED THE 48V AND 24V PSU IS WORKING PROPERLY. ADDITIONALLY, HEATER NUMBER 48 WAS REPLACED DUE TO IT BEING HOTTER THAN THE REST. THE REMAINDER OF THE SERVICE HAD TO BE CONTINUED BY A DIFFERENT FSE WHO FOUND THE CAUSE OF THE ISSUE TO BE THE HEATER CONTROL BOARD IN POSITION 3 WHICH CAUSED HEATERS 25-48 HEATERS TO TURN ON AND OVERHEAT. THIS CONTROL BOARD WAS REPLACED FOLLOWING THIS FINDING. ADDITIONALLY, OTHER RELATED COMPONENTS WERE REPLACED PROACTIVELY. THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. TESTING WAS ABLE TO BE COMPLETED USING ANOTHER INSTRUMENT. DIAGNOSTICS WERE NOT ALTERED. THE INVESTIGATION INTO THE ROOT CAUSE IS CURRENTLY ONGOING. ONCE THE INVESTIGATION HAS BEEN COMPLETED, OR IF NEW REPORTABLE INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1782492 ARTISAN LINK PRO SPECIAL STAINING SYSTEM AUTOMATED SLIDE STAINER KPA AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. AR310 05700571108451

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other