BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 23414863 · Received October 29, 2025

    Report

    Report Number
    1000113657-2025-00391
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 6, 2025
    Report Date
    October 29, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    UDI-DI
    00010939958662
    PMA / PMN Number
    K220475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). LANCETS WERE NOT RETURNED FOR EVALUATION. COMPLAINT WAS FORWARDED TO SUPPLIER QUALITY AND INTERNAL EVALUATION WAS PERFORMED BY THE MANUFACTURER USING LANCETS FROM THE SAME LOT. NO ABNORMALITIES OBSERVED WITH RETENTION SAMPLES. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-061: IMPROPER USE/MISHANDLED BY END USER. NOTE: MANUFACTURER MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS LANCETS. CUSTOMER STATED THE LANCETS ARE BENT. CUSTOMER STATED SHE TWISTS OFF THE CAP, AND IT COMES OFF EASILY BUT NOTICES THE LANCETS ARE BENT AND SHE TRIES TO POKE AND IT DOESN'T WORK AND HAS TO POKE SEVERAL TIMES TO GET BLOOD. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER STARTED USING THE PRODUCT A WEEK AGO. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE LANCETS AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216199 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, FNT 33G 100CT 24/CASE MULTICOLOR 241024TR 00010939958662

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown