BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2972034 · Received February 21, 2013

    Report

    Report Number
    2032227-2013-00687
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 6, 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 WITH A BLOOD GLUCOSE OF 1093 MG/DL. IT WAS STATED THAT THE CUSTOMER WAS VOMITING AND WAS ALSO DISORIENTED. THE CALLER STATED THAT THE CUSTOMER WAS OUT OF IT, AND DID NOT CHANGE THE INFUSION SET. THEREFORE, THE RESERVOIR WAS EMPTY. IT WAS ALSO STATED THAT THE CUSTOMER'S HEART STOPPED FOR ONE OR TWO MINUTES WHILE IN TRANSIT TO THE HOSPITAL. THE CUSTOMER WAS STILL IN THE HOSPITAL AT THE TIME OF THE CALL, AND NEEDED SUPPLIES. THE CALLER WAS TRANSFERRED TO THE CORRECT DEPARTMENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77031 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization