BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 17560194 · Received August 16, 2023

    Report

    Report Number
    1000113657-2023-00425
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    July 26, 2023
    Report Date
    October 30, 2023
    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

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 30-OCT-2023: H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. H10: RETURNED PRODUCT WAS FORWARDED TO SUPPLIER QUALITY TO CONTACT THE MANUFACTURER. MANUFACTURER'S INVESTIGATION IS ONGOING AND ROOT CAUSE SELECTED. BENT NEEDLE DEFECT ASSOCIATED WITH SCAR-23-012. ROOT CAUSE: RC-075: SUPPLIER MANUFACTURING DEFECT.

    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 (B)(6)2023 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED SHE WANTED ANOTHER REPLACEMENT BOX OF LANCETS. ADDITIONAL REPLACEMENT LANCETS SENT TO CUSTOMER.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS LANCETS. CUSTOMER WAS TRANSFERRED FROM CENTERWELL PHARMACY. CUSTOMER STATED THAT THE NEEDLES FROM HER BOX OF LANCETS ARE BENT/SLANTED WHEN THE TOP OF THE LANCET IS REMOVED. CUSTOMER ADVISED THAT PRODUCT WAS SEALED AND INTACT WHEN THE PRODUCT WAS RECEIVED. THIS IS THE FIRST TIME THE CUSTOMER USED THE PRODUCT OUT OF THIS PACKAGE. THE CUSTOMER IS NOT CLAIMING THEY WERE INJURED USING THE PRODUCT. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762231 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, TP NPD 33G 100CT50/CASE MULTICOLOR 221205NM 021292004484

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown