BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3923697 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-86597
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    CUSTOMER'S MOTHER REPORTED A HOSPITALIZATION FOR HIGH BLOOD GLUCOSE LEVELS. BEFORE THE INCIDENT, CUSTOMER WAS PLAYING BASEBALL. EVENTUALLY, CUSTOMER SAID HIS BODY WAS HURTING, HE WAS VOMITING AND MUMBLING, AND HE COULD BARELY WALK. CUSTOMER WAS TAKEN TO THE HOSPITAL, WHERE HIS BLOOD GLUCOSE LEVEL WAS 658 MG/DL. HE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. HE WAS TREATED WITH AN INSULIN DRIP. CUSTOMER WAS NOT IN AN ACCIDENT. THE DEVICE WAS TAKEN OFF WHEN CUSTOMER WENT TO THE EMERGENCY ROOM. THE DEVICE'S BASAL AND BOLUS RATES WERE CORRECT. CUSTOMER'S MOTHER CALLED BACK LATER AND STATED CUSTOMER'S BLOOD GLUCOSE LEVEL HAD STABILIZED AND WAS NOW AT 142 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399646 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization