BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 3974231 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05320
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    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 THE TRANSMITTER WOULD NOT CONNECT TO THE INSULIN PUMP AFTER RECEIVING A LOST SENSOR ALERT. SHE CONFIRMED THAT THE WRONG TRANSMITTER ID WAS NOT PROGRAMMED INTO THE INSULIN PUMP. CUSTOMER REMOVED THE SENSOR AND FOUND THAT IT WAS BENT AND THAT THERE WAS BLOOD AT THE SITE. THE BLOOD GLUCOSE READING WAS 198 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449999 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C C284

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR