BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4192620 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41491
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 IS REPORTED THAT CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014. CUSTOMER'S BLOOD GLUCOSE IS UNKNOWN. CUSTOMER WAS HOSPITALIZED DUE TO SEPSIS AND ALTERED STATE OF MIND. IT WAS REQUESTED TO HAVE AGENT FROM MEDTRONIC ATTEND THE HOSPITAL TO ASSURE CUSTOMER'S INSULIN PUMP IS FUNCTIONING PROPERLY. HEALTH CARE PROFESSIONAL WAS NOT ABLE TO TROUBLESHOOT AND GIVE INFORMATION OF HOSPITALIZATION. HEALTH CARE PROFESSIONAL WAS GIVEN CONTACT INFORMATION FOR THE DIABETES CARE MANAGER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672453 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization