BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841657 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-85266
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    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 REPORTED THAT THE INSULIN PUMP WAS LEAKING. CUSTOMER HOSPITALIZAED DUE TO DIABETES KETOACIDOSIS. BLOOD GLUCOSE READING WAS HIGHL. CUSTOMER STATED THAT IT HURT HER TO INSERT THE CANNULA, SINCE SHE HAD A SCAR FROM THE SURGERY SHE HAD. CUSTOMER WAS HOSPITALIZED SEVERAL TIMES. CUSTOMER'S BLOOD GLUCOSE WAS OVER 1000 MG/DL AT TIMES. THE LAST BLOOD GLUCOSE WAS 138 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318506 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization