BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 17670585 · Received September 1, 2023

    Report

    Report Number
    1000113657-2023-00454
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 7, 2023
    Report Date
    January 18, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    UDI-DI
    021292004484
    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 18-JAN-2024: D4: MODEL NUMBER UPDATED FROM "LCT, TP NPD 33G 100CT 50/CASE MULTICOLOR" TO "LCT, TP NPD 30G 100CT50/CASE DK BL", LOT NUMBER UPDATED FROM "221205NM" TO "181057NM", EXPIRATION DATE UPDATED FROM "09-JAN-2028" TO "10-NOV-2023" AND UNIQUE IDENTIFIER (UDI) # UPDATED FROM "(B)(4)." H3: WAS THE DEVICE EVALUATED BY THE MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. LANCETS WERE NOT RETURNED FOR EVALUATION - CUSTOMER HAD RETURNED THE INCORRECT LANCETS, SCRAPPED DUE TO INCORRECT PRODUCT RECEIVED. 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). ADDITIONAL REPORT REFERENCE (B)(4): CUSTOMER'S INITIAL CALL. LANCETS WERE RETURNED - PRODUCT EVALUATION IN-PROCESS. RETURNED PRODUCT WAS FORWARDED TO SUPPLIER QUALITY TO CONTACT THE MANUFACTURER. MANUFACTURER'S INVESTIGATION IS ONGOING. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 15-AUG-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; COMPLAINT WAS FOR REPLACEMENT LANCETS (INTERNAL REPORT REFERENCE (B)(4). CUSTOMER ADVISED THAT SHE RECEIVED REPLACEMENT LANCETS THAT WERE SHIPPED TO HER AND THAT THE NEEDLES ARE STILL BENT. ENSURED THAT CUSTOMER WAS AGAIN NOT BENDING THE PROTECTIVE CAP FROM SIDE TO SIDE AND THAT SHE WAS TWISTING THE CAP A FEW TIMES AND THEN PULLING OFF THE CAP. CUSTOMER IS FEELING WELL AND IS NOT HAVING ANY DIABETIC 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
    1262107 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, TP NPD 30G 100CT50/CASE DK BL 181057NM 021292004484

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown