BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 17224552 · Received June 29, 2023

    Report

    Report Number
    3005798905-2023-03126
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 28, 2023
    Report Date
    June 28, 2023
    Manufacturer
    FEEL TECH BIO CO., LTD.
    Product Code
    FMI
    PMA / PMN Number
    K112789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE WAS RETURNED TO THE CMO ON 08-02-2023 TESTING, DURING DEVICE TESTING THE CMO FOUND NO IRREGULARITIES AND THE DEVICE WAS FOUND TO BE IN GOOD WORKING CONDITION.

    Additional Manufacturer Narrative · 0

    INITIAL TREND ANALYSIS FOR LOT 556603P WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 556603P. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 0

    USER STATES THE EASY TOUCH PEN NEEDLES ITEM NUMBER 832081, LOT 556603P ARE CLOGGED WHEN USING WITH A LANTUS SOLASTAR INSULIN PEN. NO INSULIN WILL COME OUT OF THE NEEDLE WHEN PRIMING THE PEN NEEDLE. HOWEVER, ONCE THE PN IS REMOVED FROM THE INSULIN PEN THE INSULIN WILL LEAK OUT.

    Description of Event or Problem · 0

    USER STATES THE EASYTOUCH PEN NEEDLES ITEM NUMBER 832081 LOT 556603P ARE CLOGGED WHEN USING WITH A LANTUS SOLASTAR INSULIN PEN. NO INSULIN WILL COME OUT OF THE NEEDLE WHEN PRIMING THE PEN NEEDLE. HOWEVER, ONCE THE PN IS REMOVED FROM THE INSULIN PEN THE INSULIN WILL LEAK OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264665 EASYTOUCH PEN NEEDLE FMI FEEL TECH BIO CO., LTD. 556603P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown