BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 16147140 · Received January 12, 2023

    Report

    Report Number
    1000113657-2023-00015
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 15, 2022
    Report Date
    February 22, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    UDI-DI
    00096295125672
    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). 9 LANCETS WERE RETURNED FOR EVALUATION. EVALUATION IN PROCESS COMPLAINT WAS FORWARDED TO SUPPLIER QUALITY BASED ON COMPLAINT'S DESCRIPTION FOR INVESTIGATIONS. INTERNAL EVALUATION HAS BEEN COMPLETED BY THE MANUFACTURER. NO ABNORMALITIES OBSERVED WITH RETENTION SAMPLES. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2022 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 22-FEB-2023: H3: DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. H10: MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED AND ROOT CAUSE SELECTED. NO ABNORMALITIES OBSERVED ON RETURNED PRODUCT, RETAIN SAMPLES, AND REVIEW BATCH RECORD. ALL THE TEST RESULTS MEETS THE REQUIREMENTS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-061: IMPROPER USE/MISHANDLED BY END USER.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR THE 30G LANCETS. COMPLAINT WAS INITIALLY REPORTED BY DISTRIBUTOR VIA E-MAIL AND CUSTOMER WAS CONTACTED VIA TELEPHONE. CUSTOMER STATED THAT THE NEEDLE HAD COME OFF WHEN HE PULLED THE TOP OFF THE LANCETS. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE FOR 2 WEEKS. CUSTOMER IS USING A COMPETITOR'S LANCING DEVICE. 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
    1258966 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, TP LDR 30G 100CT50/CASE DK BL 200803NM 00096295125672

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown