BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROLET2 LANCING DEVICE

    MDR report key: 1984449 · Received January 31, 2011

    Report

    Report Number
    1826988-2011-00041
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LANCING DEVICES ARE NOT SERIALIZED OR ASSIGNED LOT NUMBERS, SO IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE. LANCING DEVICES ARE ALSO NOT 510K CLEARED.

    Description of Event or Problem · 1

    A BAYER SALES REPRESENTATIVE CALLED ON BEHALF OF A (B)(6) DIABETES NURSE EDUCATOR. HE STATED THE NURSE WAS HAVING DIFFICULTY REMOVING THE ENDCAP ON A MICROLET2 LANCING DEVICE AND RECEIVED A NEEDLESTICK FROM A USED LANCET. THE LANCET HAD BEEN USED ON A PT WHO HAD (B)(6). THE CALLER SAID THE NURSE WAS TESTED FOR (B)(6) AND SHE WAS FINE. CUSTOMER SERVICE LEFT A MESSAGE FOR THE NURSE AND ADVISED HER TO RETURN THE MICROLET2 FOR EVAL. A REPLACEMENT LANCING DEVICE WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROLET2 LANCING DEVICE NBW BAYER HEALTHCARE, LLC NOT PROVIDED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK