BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTO-LANCET

    MDR report key: 306238 · Received November 27, 2000

    Report

    Report Number
    MW1020484
    Event Type
    Other
    Date Received
    November 27, 2000
    Date of Event
    October 16, 2000
    Report Date
    October 16, 2000
    Manufacturer
    PALCO LABS, INC.
    Product Code
    FMK
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT REPORTED LANCET DEVICE WORKED CORRECTLY FOR ONE WEEK, HOWEVER IT NOW DOES NOT STICK DEEP ENOUGH TO PROVIDE AN ADEQUATE BLOOD SAMPLE. THE LANCET IS CURRENTLY SET TO THE DEEPEST SKIN PENETRATION. PT DOES NOT HAVE ORIGINAL BOX WITH LOT #. PHARMACY IS CURRENTLY DISPENSING LOT # 080061. THERE IS A HIGH PROBABILITY IT CAME FROM THIS LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO-LANCET LANCET FOR MEASURING BLOOD GLUCOSE FMK PALCO LABS, INC. PRODUCT # REF AL100MK6AS 080061

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other