BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 18274905 · Received December 6, 2023

    Report

    Report Number
    1000113657-2023-00589
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 10, 2023
    Report Date
    March 27, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    PMA / PMN Number
    K220475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 27-MAR-2024: H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: COMPLAINT WAS FORWARDED TO SUPPLIER QUALITY AND INTERNAL EVALUATION WAS PERFORMED BY THE MANUFACTURER USING LANCETS FROM THE SAME LOT. NO ABNORMALITIES OBSERVED WITH RETENTION SAMPLES AND DHR. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-009: USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). LANCETS WERE RETURNED - RECEIVED 10 USED LANCETS, CAP HAS BEEN TWISTED OFF AND PLUGGED BACK ON; UNABLE TO SHIP TO THE MANUFACTURER DUE TO NEEDLE EXPOSED. 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 REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS 33G LANCETS. CUSTOMER STATED THAT WHEN HE TWISTS THE PROTECTIVE CAP, THE CAP DOES NOT COME OFF FROM THE NEEDLE, IT STAYS STUCK, AND THAT THE NEEDLE COMES OFF FROM THE LANCET. CUSTOMER STATED THIS HAPPENED WITH ABOUT 20 OF THE LANCETS. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT OUT OF THE PACKAGE FOR A FEW WEEKS. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE LANCETS AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180724 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, TP HMT 33G 100CT24/CASE MULTICOLOR 221027NM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown