BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 16630149 · Received March 28, 2023

    Report

    Report Number
    1000113657-2023-00168
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    March 1, 2023
    Report Date
    May 18, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    UDI-DI
    00096295125665
    PMA / PMN Number
    K220475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 18-MAY-2023: H3: DEVICE EVALUATED BY MANUFACTURER. 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 HAS BEEN COMPLETED AND ROOT CAUSE SELECTED. REPORTED DEFECT NOT REPRODUCED. NO ABNORMALITIES OBSERVED WITH RETURNED SAMPLES, RETENTION SAMPLES AND BATCH RECORD. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-061: IMPROPER USE/MISHANDLED BY END USER.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(6). LANCETS WERE RETURNED - PRODUCT EVALUATION IN-PROCESS. MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2023 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN, ABLE TO CONTACT CUSTOMER WHO STATED THEY ARE COMFORTABLE WITH THE REPLACEMENT PRODUCTS.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS LANCETS. CUSTOMER ADVISED THAT SOME OF THE LANCETS FROM THE BOX WERE BENT WHEN SHE REMOVED THE PROTECTIVE COVERING TO EXPOSE THE NEEDLE. CUSTOMER ADVISED THAT PRODUCT WAS SEALED AND INTACT WHEN SHE RECEIVED IT. THE CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THIS PACKAGE SINCE (B)(6) 2022. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER DID NOT CLAIM TO BE INJURED USING THE LANCETS AND NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555445 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, TP LDR 33G 100CT50/CASE MULTICOLOR 211005NM 00096295125665

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown