BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2991794 · Received March 6, 2013

    Report

    Report Number
    2032227-2013-00905
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 18, 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 DUE TO HIGH BLOOD GLUCOSE LEVELS AND A URINARY TRACT INFECTION. THE REPORTED BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 456 MG/DL. IT WAS ALSO STATED THAT THE CUSTOMER'S KIDNEYS ARE FAILING. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST. IT WAS STATED THAT THE DOCTOR MADE SURE THAT THE INSULIN PUMP WAS WORKING AS DESIGNED, AND IT WAS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96277 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization