BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 19518151 · Received June 12, 2024

    Report

    Report Number
    1000113657-2024-00251
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 15, 2024
    Report Date
    September 20, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    UDI-DI
    021292004484
    PMA / PMN Number
    K220475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). LANCETS WERE RETURNED - PRODUCT EVALUATION IN PROCESS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-028: THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE MLURC. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 05-JUN-2024 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 20-SEP-2024: LANCETS WERE RETURNED: UNABLE TO SHIP RETURNED PRODUCT TO THE 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. MLC-028: THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE MLURC.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS LANCETS. CUSTOMER STATED THAT WHEN SHE TWISTS THE PROTECTIVE NEEDLE COVER A COUPLE OF TIMES AND THEN ATTEMPTS TO PULL IT OFF, THE NEEDLE COMES OFF IN THE PROTECTIVE COVER. CUSTOMER ADVISED THAT THIS ONLY HAPPENED WITH THE GREEN LANCETS. THE BOX WAS SEALED AN INTACT WHEN IT WAS PURCHASED BY THE CUSTOMER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389508 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, TP NPD 33G 100CT 50/CASE MULTICOLOR 230707TR 021292004484

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown