BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET DEVICE SNSRTR CMFRT EN

    MDR report key: 4183138 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40148
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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

    CUSTOMER REPORTED HE WAS TRYING TO INSERT HIS SENSORS AND THE SERTER WOULD NOT RELEASE THE NEEDLE. CUSTOMER TRIED INSERTING ANOTHER SENSOR AND HAD TO USE A KNIFE TO TRY AND KEEP THE SENSOR ON. IT ENDED UP FALLING OFF. CUSTOMER STATED THAT BOTH THE BUTTON PRESSES WORKED, BUT WHEN REMOVING THE SERTER IT PULLS OUT THE SENSOR. THE NEEDLE HUB WAS STUCK IN THE SERTER. CUSTOMER'S BLOOD GLUCOSE WAS 123 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660121 LANCET DEVICE SNSRTR CMFRT EN CGM MDS MEDTRONIC MINIMED MMT-7510

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR