BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 24782039 · Received April 3, 2026

    Report

    Report Number
    1000113657-2026-00157
    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
    021292004460
    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 RETURNED - PRODUCT EVALUATION IN-PROCESS. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 20-MAR-2026 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 22-MAY-2026: H3: WAS THE DEVICE EVALUATED BY THE MANUFACTURER AND IF THE DEVICE WAS NOT EVALUATED, DEVICE WAS NOT EVALUATED, SELECTED THE APPROVED FDA CODES OR SELECT 'OTHER' AND ENTER TEXT IN H10. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: LANCETS WERE RETURNED - UNABLE TO SHIP RETURNED PRODUCT TO MANUFACTURER DUE TO BIOHAZARD. RETURN 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.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS LANCETS. THE CUSTOMER STATED THAT WHEN HE TWISTS OFF THE TOP OF THE LANCET THE NEEDLE COMES RIGHT OUT OF THE CASING. PER THE CUSTOMER THE PACKAGE WAS NO OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PRODUCT SINCE (B)(6) 2025. 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 PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93640 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, TP NPD 30G 100CT50/CASE DK BL 250718NM 021292004460

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown