BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 23153493 · Received September 26, 2025

    Report

    Report Number
    1000113657-2025-00335
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    September 3, 2025
    Report Date
    September 26, 2025
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    PMA / PMN Number
    K220475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). LANCETS WERE RETURNED - UNABLE TO SHIP RETURNED PRODUCT TO THE MANUFACTURER DUE TO BIOHAZARD. RETURNED PRODUCT SCRAPPED. 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-009: USE ERROR CAUSED OR CONTRIBUTED TO EVENT. 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 THE TRUEPLUS LANCETS. CUSTOMER STATED THAT THE 30G LANCETS ARE DULL, AND THEY WERE UNABLE TO OBTAIN A BLOOD SAMPLE. CUSTOMER STATED THAT SHE USES THE LANCING DEVICE ON DIFFERENT SETTINGS, AND IT STILL DOES NOT MAKE A DIFFERENCE. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR 1 WEEK. 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
    2123490 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, TP NPD 30G 100CT50/CASE DK BL 241022NM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown