BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PERSONAL

    MDR report key: 4133312 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-10555
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THERE WAS A NICK IN THE TUBING AND THAT INSULIN WAS LEAKING AND DRIPPING OUT ONTO THE FLOOR. THE BLOOD GLUCOSE HAD BEEN RUNNING HIGH AND HE FELT HE WAS NOT RECEIVING THE INSULIN DELIVERY. HE ALSO REPORTED THAT THE ADHESIVE WOULD STICK TO THE INSERTER. NO BLOOD GLUCOSE READING WAS GIVEN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611049 CARELINK PERSONAL CGM MDS MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR