BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 16466738 · Received March 2, 2023

    Report

    Report Number
    1000113657-2023-00122
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    February 3, 2023
    Report Date
    March 2, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    UDI-DI
    021292004484
    PMA / PMN Number
    K220475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). LANCETS WERE NOT RETURNED FOR EVALUATION. CUSTOMER RETURNED INCORRECT TRUE PLUS LANCETS COMPLAINT WAS FORWARDED TO SUPPLIER QUALITY AND INTERNAL EVALUATION HAS BEEN COMPLETED BY THE MANUFACTURER. NO ABNORMALITIES OBSERVED WITH RETENTION SAMPLES AND DHR REPORT. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-061: IMPROPER USE/MISHANDLED BY END USER. 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 BENT LANCET. CUSTOMER STATED SHE HAD OPENED FIVE LANCETS AND ALL WERE BENT. CUSTOMER IS TRYING TO USE THE LANCETS FOR THE FIRST TIME. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT IS REPORTED. THE LANCET LOT MANUFACTURER¿S EXPIRATION DATE IS 06/28/2027 AND OPEN VIAL DATE IS UNDISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2012414 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, TP NPD 33G 100CT50/CASE MULTICOLOR 220603NM 021292004484

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown