BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET-100

    MDR report key: 17267965 · Received July 6, 2023

    Report

    Report Number
    1000113657-2023-00360
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 12, 2023
    Report Date
    July 6, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    QRK
    PMA / PMN Number
    K220475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). LANCETS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-028: THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE MLURC. NOTE 1:MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 20-JUN-2023 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED SHE HAD JUST RECEIVED THE REPLACEMENT PRODUCT AND HAS NOT YET USED IT. NOTE 2:MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS LANCETS. CUSTOMER STATED THAT WHEN THE LANCET IS REMOVED FROM THE LANCING DEVICE THE NEEDLE IS BENT. CUSTOMER STATED THE LANCET NEEDLE WAS NOT BENT PRIOR TO INSERTION INTO THE LANCING DEVICE. THE LOT NUMBER OF THE LANCETS WAS NOT PROVIDED. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR A FEW DAYS. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884755 LANCET-100 LANCET, BLOOD QRK TRIVIDIA HEALTH INC LCT, TP NPD 28G 100CT50/CASE LT BL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown