BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 20304783 · Received September 25, 2024

    Report

    Report Number
    1000113657-2024-00389
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    September 3, 2024
    Report Date
    November 4, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    UDI-DI
    021292004484
    PMA / PMN Number
    K220475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 04-NOV-2024: H3: WAS THE DEVICE EVALUATED BY THE MANUFACTURER AND IF THE DEVICE WAS NOT EVALUATED, SELECT FROM THE APPROVED FDA CODES OR SELECT 'OTHER' AND ENTER TEXT IN H10. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: LANCETS WERE RETURNED - UNABLE TO BE SHIPPED TO MANUFACTURER DUE TO BIOHAZARD. RETURN PRODUCT SCRAPPED. 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. 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 19-SEP-2024 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO INDICATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS LANCETS; COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND CUSTOMER WAS CONTACTED BY TELEPHONE. CUSTOMER STATED THAT THE LANCETS BARELY MADE A PUNCTURE AND THAT SOME OF THE ROUND TWIST TOPS WERE MISSING. CUSTOMER STATED THE PRODUCT HAD BEEN SEALED AND INTACT WHEN RECEIVED. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR ONE WEEK. 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
    1291762 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, TP NPD 33G 100CT50/CASE MULTICOLOR 231113TR 021292004484

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown