BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET DEVICE

    MDR report key: 4190515 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41070
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHE WAS HAVING DIFFICULTY INSERTING HER BLOOD GLUCOSE SENSORS. HER BLOOD GLUCOSE WAS 164MG/DL AT THE TIME OF REPORTING. SHE STATED THAT WHEN SHE INSERTED THE SENSOR THE FIRST TIME IT WAS PAINFUL AND WHEN SHE REMOVED IT THE NEEDLE WAS BENT. SHE ALSO REPORTED THAT THE SENSOR WAS BECOMING STUCK IN THE IN THE INSERTER, AND WAS CAUSING IT TO DISLODGE. THE CUSTOMER WAS ADVISED TO RETURN THE SENSOR AS WELL AS THE INSERTER, BOTH OF WHICH WOULD BE REPLACED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668703 LANCET DEVICE CGM MDS MEDTRONIC MINIMED MMT-7510

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR