BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 24778553 · Received April 3, 2026

    Report

    Report Number
    1000113657-2026-00156
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 10, 2026
    Report Date
    May 22, 2026
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    UDI-DI
    021292004484
    PMA / PMN Number
    K220475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). LANCETS WERE NOT RETURNED FOR EVALUATION. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 01-APR-2026 TO ENSURE THE CUSTOMER¿S INITIAL CONCERN WAS RESOLVED- THE CUSTOMER IS COMFORTABLE WITH THE REPLACEMENT PRODUCTS.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR THE NEEDLE IS COMING OFF WHEN TWISTING THE TOP OFF THE TRUEPLUS LANCETS. THE CUSTOMER STATED THAT IT IS 2 BOXES THAT SHE IS HAVING THE ISSUE WITH: BOTH THE SAME LOT NUMBER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/06/2030 AND PER THE CUSTOMER THE OPEN VIAL DATE IS UNDISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29624 LANCET-100 BLOOD LANCETS QRK TRIVIDIA HEALTH INC LCT, TP NPD 33G 100CT50/CASE MULTICOLOR 250311TR 021292004484

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown