BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINGFISHER DNA EXTRACTOR THERMO FISHER

    MDR report key: 10698382 · Received October 16, 2020

    Report

    Report Number
    MW5097305
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Report Date
    March 3, 2025
    Manufacturer
    THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
    Product Code
    LXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5097305 TO ADD AN ADDITIONAL DEVICE, UPDATE SERIAL NUMBER AND TO CHANGE PROCODE. REFERENCE REPORT: MW5167161. PROCODE: LXG.

    Description of Event or Problem · 1

    THE KINGFISHER SPLANKER WHEN EXTRACTING DNA. THIS RESULTS IN CONTAMINATION OF THE OTHER SAMPLES IN THE PLATE WITH POSITIVE CONTROLS THAT ARE BEING EXTRACTED. THIS RESULTS IN FALSE POSITIVE REPORTING FOR COVID-19 RESULT. THERE ARE ALSO TIP CARE ISSUES WITH THE MACHINE SPECIALLY WITH THE ALTERNATE PLANTATION THAT THE MANUFACTURER IS SELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152749 KINGFISHER DNA EXTRACTOR THERMO FISHER EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDIC LXG THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC KINGFISHERFLEX
    1152750 KINGFISHER DNA EXTRACTOR THERMO FISHER ANALYZER, CHROMOSOME, AUTOMATED LXG THERMO FISHER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown