BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 18769487 · Received February 23, 2024

    Report

    Report Number
    1000113657-2024-00081
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 29, 2024
    Report Date
    March 28, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    UDI-DI
    021292004484
    PMA / PMN Number
    K220475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). 1 BOX TRUE PLUS LANCETS WERE RETURNED - UNABLE TO SHIP RETURNED PRODUCT TO THE MANUFACTURER, DUE TO BIOHAZARD. SCRAP RETURNED PRODUCT. MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 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; 28-MAR-2024. H10: COMPLAINT WAS FORWARDED TO SUPPLIER QUALITY BASED ON COMPLAINT'S DESCRIPTION FOR INVESTIGATIONS. CUSTOMER RETURNED USED LANCETS, CAP HAS BEEN TWISTED OFF AND PLUGGED BACK ON, UNABLE TO SHIP TO THE MANUFACTURER DUE TO NEEDLE EXPOSED. SCRAP RETURNED PRODUCT. INTERNAL EVALUATION HAS BEEN COMPLETED BY THE MANUFACTURER. NO ABNORMALITIES OBSERVED WITH RETENTION SAMPLES AND DHR. ADDED MOST LIKELY UNDERLYING ROOT CAUSE ONTO CASE. 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. CUSTOMER STATED THAT SOME OF THE 33G LANCETS WERE BENDING WHEN SHE IS RECAPPING. CUSTOMER ADVISED THAT SHE IS TWISTING THE CAP AND THEN PULLING THE TOP PORTION OFF BUT THAT WHEN SHE TRIES TO "RECAP" THE NEEDLES, THEY ARE ALL BENDING. CUSTOMER STATED THAT ON THE BACK OF THE BOX OF LANCETS IT SAYS HOW THE NEEDLE SHOULD BE RECAPPED. CUSTOMER STATED THAT THE NEEDLES ARE POOR QUALITY AS THEY SHOULD NOT BE BENDING. CUSTOMER HAS BEEN USING THE PRODUCT FOR A FEW WEEKS. 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
    114616 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, TP NPD 33G 100CT50/CASE MULTICOLOR 230327NM 021292004484

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown