BEUDAMED
    FDA Adverse Event Other Summary report: N

    FINGERSTIX

    MDR report key: 270699 · Received March 16, 2000

    Report

    Report Number
    1810909-2000-00009
    Event Type
    Other
    Date Received
    March 16, 2000
    Date of Event
    February 16, 2000
    Report Date
    March 15, 2000
    Manufacturer
    BAYER CORP.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED FROM A POLICE INVESTIGATOR. POLICE INVESTIGATOR INDICATED THAT A SOCIAL WORKER SAMPLED BLOOD FROM A STUDENT THAT WAS FEELING LETHARGIC. ANOTHER STUDENT ASKED TO BE TESTED AND THE SOCIAL WORKER SAMPLED THE SECOND STUDENT WITH THE SAME LANCET USED ON THE FIRST STUDENT. (THE SOCIAL WORKER DID NOT CHANGE THE LANCET). PRODUCT LABELING CLEARLY STATES THAT A NEW FINGERSTIX (LANCET) MUST BE USED FOR EACH INDIVIDUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINGERSTIX BLOOD LETTING DEVICE FMK BAYER CORP. 6540 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN