BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 23695148 · Received December 2, 2025

    Report

    Report Number
    1000113657-2025-00443
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 4, 2025
    Report Date
    December 2, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER WAS NOT RETURNED FOR EVALUATION. CUSTOMER RETURNED A VIAL OF TEST STRIP WITHOUT THE SEAL, UNABLE TO INVESTIGATE. SCRAP RETURNED PRODUCT. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. COMPLAINT WAS FORWARDED TO PACKAGING AND INTERNAL EVALUATION COMPLETED. PACKAGING RECORDS WERE REVIEWED, NO ABNORMALITIES OBSERVED. 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 REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR MISSING SAFETY SEAL. THE CUSTOMER CALLED CONCERNED AS HE HAD PURCHASED A BOX OF STRIPS 100 COUNT AND WHEN HE OPENED THE SEALED BOX ONE VIAL HAD THE SAFETY SEAL AND THE OTHER VIAL DID NOT. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/19/2027; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912536 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT12/CS MG/DL #383569 ZD6158S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown