BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEPLUS LANCETS

    MDR report key: 23336799 · Received October 20, 2025

    Report

    Report Number
    1000113657-2025-00380
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 20, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    PMA / PMN Number
    K220475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). LANCETS WERE NOT RETURNED FOR EVALUATION. PRODUCT INFORMATION/LOT NUMBER NOT PROVIDED; SUPPLIER UNABLE TO INVESTIGATE. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-028: THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE MLURC. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE INITIAL CONCERN IS RESOLVED - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS LANCETS. CUSTOMER REPORTED THAT THE LANCETS WERE "NOT PUNCTURING THE SKIN AS WELL AS OTHERS". CUSTOMER REPORTED THAT THE "HIGHEST SETTING BARELY PIERCES" THE SKIN. PRODUCT INFORMATION, INCLUDING LOT NUMBER, WAS NOT PROVIDED. COMPLAINT WAS REPORTED VIA E-MAIL; ATTEMPTED TO CONTACT CUSTOMER BY PHONE, UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801810 TRUEPLUS LANCETS LANCET, BLOOD QRK TRIVIDIA HEALTH INC TRUEPLUS REGULAR LANCETS 30 GAUGE 100CT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown