BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4090415 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23111
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED CUSTOMER WAS IN THE HOSPITAL DUE TO LOW BLOOD GLUCOSE. 911 WAS CALLED ON (B)(6) 2014 AND CUSTOMER WAS ADMITTED TO THE HOSPITAL WITH A BLOOD GLUCOSE OF 62 MG/DL. CUSTOMER IS CURRENTLY IN THE HOSPITAL FOR OBSERVATION AND TO ADJUST CUSTOMER'S SETTINGS. LEADING UP TO THE EVENT, CUSTOMER'S LEFT SIDE WAS NUMB. CUSTOMER WAS KEPT OVERNIGHT FOR AN MRI. THE DOCTORS BELIEVE CUSTOMER MAY HAVE HAD A SEIZURE DUE TO THE LOW BLOOD GLUCOSE. CUSTOMER'S LAST BLOOD GLUCOSE WAS 302 MG/DL. CUSTOMER WAS EDUCATED ON DEVICE SETTINGS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568775 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 MO Hospitalization