BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3894863 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03371
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE READING AT THE HOSPITALIZATION WAS UNKNOWN. NO SIGNIFICANT EVENTS LEADING TO THE EMERGENCY ROOM VISIT WERE OBSERVED. THE CUSTOMER WAS NOT IN AN ACCIDENT. THE CUSTOMER'S DAUGHTER REPORTED THAT HE WAS STILL BEING TREATED AT THE TIME OF THE CALL. SHE CONFIRMED THAT HE WAS WEARING THE PUMP AT THE TIME OF THE EMERGENCY ROOM VISIT AND REQUESTED ASSISTANCE ON HOW TO NAVIGATE THE BOLUS HISTORY ON THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370338 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization