BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3180911 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-94877
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    October 11, 2012
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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 IN THE EMERGENCY ROOM DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE. THE CALLER STATED THAT THE CUSTOMER WAS PREGNANT AND LOST THE BABY. IT WAS UNSURE IF THE BABY'S DEATH WAS THE REASON SHE WENT INTO IT. THE MOTHER STATED THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN. THE CUSTOMER EXPERIENCED KETONES, NAUSEA, AND VOMITING. IT WAS STATED THAT THE CUSTOMER WAS DISCONNECTED FROM THE INSULIN PUMP AND HER BLOOD GLUCOSE WAS TREATED WITH AN INSULIN DRIP. ADVISED THE CALLER TO CALL BACK WHEN THE TUBING CLAMP ARRIVES TO TROUBLESHOOT THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281257 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization