BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 19168857 · Received April 23, 2024

    Report

    Report Number
    1000113657-2024-00177
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    April 9, 2024
    Report Date
    April 23, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    PMA / PMN Number
    K220475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4) . LANCETS WERE NOT RETURNED FOR EVALUATION. NOTE: MANUFACTURER WAS UNABLE TO CONTACT CUSTOMER IN FOLLOW-UP CALL TO ENSURE THE INITIAL CONCERN IS RESOLVED - CUSTOMER DECLINED TO PROVIDE THEIR CONTACT INFORMATION.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS LANCETS. CUSTOMER STATED THAT THE NEEDLES ON THE LANCETS ARE BENT. CUSTOMER STATED SHE ATTEMPTED TO TEST HER BLOOD GLUCOSE THREE TIMES AND DUE TO THE NEEDLES BEING BENT IS UNABLE TO OBTAIN A SUFFICIENT BLOOD SAMPLE NEEDED TO PERFORM THE TEST. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER DID NOT PROVIDE THE LOT INFORMATION FOR THE LANCETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070330 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, TP NPD 28G 100CT50/CASE LT BL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown