BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 24532811 · Received March 6, 2026

    Report

    Report Number
    3005798905-2026-00002
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 5, 2026
    Report Date
    April 6, 2026
    Manufacturer
    BERPU MEDICAL TECHNOLOGY CO., LTD
    Product Code
    FMF
    PMA / PMN Number
    K102178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER CMO, "NO ABNORMALITIES WERE FOUND IN THE MANUFACTURING PROCESS OR RETAINED SAMPLES. THIS IS THE ONLY COMPLAINT FOR THIS BATCH. OUR ANALYSIS SUGGESTS THAT IT MAY BE RELATED TO USER HANDLING." TWENTY RETAINED SAMPLES FROM THE COMPLAINED BATCHES WERE TESTED FOR PENETRATION FORCE. THE RESULTS FOR BATCH 72972 RANGED FROM 0.431 N TO 0.546 N, AND FOR BATCH 72976 RANGED FROM 0.434 N TO 0.550 N, BOTH MEETING THE STANDARD REQUIREMENT OF "MAXIMUM PENETRATION FORCE <0.70 N."

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN RETURNED TO OUR FACILITY AND WILL BE SHIPPED BACK TO THE MFR FOR INVESTIGATION. THEY HAVE BEEN NOTIFIED OF THE PROBLEM AND ARE INVESTIGATING. AN ADDITIONAL REPORT WILL BE FILED FOLLOWING THAT INVESTIGATION WITH ALL ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    END USER EMAILED STATING THAT TO DIFFERENT LOTS THEY HAVE BOUGHT ARE BOTH DULL. EMAILED END USER AWAITING RESPONSE

    Description of Event or Problem · 0

    END USER EMAILED STATING THAT TO DIFFERENT LOTS THEY HAVE BOUGHT ARE BOTH DULL. EMAILED END USER AWAITING RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25934 EASYTOUCH INSULIN SYRINGE FMF BERPU MEDICAL TECHNOLOGY CO., LTD 72972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown