BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2993332 · Received March 7, 2013

    Report

    Report Number
    2032227-2013-00920
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED AFTER EXPERIENCING SEIZURES AND A BLOOD GLUCOSE OF 368 MG/DL. THE CALLER STATED THAT THE CUSTOMER WAS VERY DISORIENTED, AND DIDN'T KNOW WHO SHE WAS OR WHO HER MOTHER WAS. THE CALLER STATED THAT THE CUSTOMER COULD NOT FIND HER INSULIN PUMP. IT WAS STATED THAT, AT THE TIME OF THE SEIZURES, THE CUSTOMER CAME TO AT A STORE, AND SHE REMEMBERS FEELING LIKE SOMETHING WAS POKING HER IN HER STOMACH. IT WAS STATED THAT THE CUSTOMER MAY HAVE REMOVED THE INSULIN PUMP AT THAT TIME. THE CUSTOMER WAS STILL IN THE HOSPITAL AT THE TIME OF THE CALL. TROUBLESHOOTING WAS NOT POSSIBLE AS THE INSULIN PUMP STILL HAS NOT BEEN FOUND. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97190 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization