BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143015 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30218
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    May 18, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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

    CUSTOMER'S DAUGHTER REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH A BLOOD GLUCOSE OVER 500 MG/DL AND DIABETIC KETOACIDOSIS. SHE REPORTED SYMPTOMS OF VOMITING, HEADACHE AND LETHARGY. THE CUSTOMER WAS NOT IN AN ACCIDENT. CUSTOMER WAS TREATED FOR THREE DAYS. CUSTOMER'S DAUGHTER STATED THAT THERE WERE NO SIGNS THAT ANYTHING WAS WRONG WITH THE INSULIN PUMP AND THAT THE CUSTOMER HAD BEEN TREATING WITH BOLUSES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603507 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization