BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 18072786 · Received November 6, 2023

    Report

    Report Number
    1000113657-2023-00539
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 11, 2023
    Report Date
    December 20, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    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 20-DEC-2023: H3: WAS THE DEVICE EVALUATED BY THE MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: LANCETS WERE RETURNED FOR EVALUATION. RETURNED PRODUCT WAS FORWARDED TO SUPPLIER QUALITY AND INTERNAL EVALUATION WAS PERFORMED BY THE MANUFACTURER. NO ABNORMALITIES OBSERVED ON RETURNED PRODUCT AND RETAIN SAMPLES. ALL THE TEST RESULTS MEET THE REQUIREMENTS. 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 - PRODUCT EVALUATION IN-PROCESS. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 26-OCT-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 LANCETS. CUSTOMER STATED THAT WHEN SHE ATTEMPTS TO REMOVE THE LANCET COVER FORM THE LANCET, THE NEEDLE IS COMING OFF WHEN SHE PULLS OFF THE PROTECTIVE CAP. CUSTOMER STATED THAT SHE DOES TWIST THE PROTECTIVE CAP FIRST A FEW TIMES AND THEN PULLS THE PROTECTIVE CAP OFF. CUSTOMER STATED THAT THE BOX HAD NOT BEEN OPENED BUT THERE WAS SOME CRUSHING OF THE BOX WHEN IT WAS RECEIVED. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR ABOUT ONE MONTH. THE 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
    2208292 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, TP NPD 30G 100CT 50/CASE DK BL 210707NM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown