BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROLET2 LANCING DEVICE

    MDR report key: 1844887 · Received September 22, 2010

    Report

    Report Number
    1826988-2010-00652
    Event Type
    Injury
    Date Received
    September 22, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    FMK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A 510K NUMBER WAS NOT PROVIDED BECAUSE LANCING DEVICES ARE NOT 510K CLEARED. LANCING DEVICES ARE NOT SERIALIZED OR ASSIGNED LOT NUMBERS SO IT'S NOT POSSIBLE TO DETERMINE A MANUFACTURE DATE.

    Description of Event or Problem · 1

    THE ADVOCATE CALLED FOR HELP WITH THE CUSTOMER'S MICROLET2 LANCING DEVICE. AFTER THE CUSTOMER USED THE DEVICE TO OBTAIN A SAMPLE, THE ADVOCATE ACCIDENTALLY STUCK HERSELF WHEN TRYING TO REMOVE THE USED LANCET. NO OTHER INFO WAS PROVIDED. THE DEVICE IS TO BE RETURNED FOR EVALUATION. A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROLET2 LANCING DEVICE FMK BAYER HEALTHCARE LLC 6606 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK