BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3253325 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-96208
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 5, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM SEVERAL TIMES DUE TO HIGH BLOOD GLUCOSE OVER 600MG/DL AND CELLULITIS INFECTION. THE CALLER EXPERIENCED NAUSEA AND HEADACHES. THE CUSTOMER STATED THAT SHE WAS WEARING THE INSULIN PUMP THE FIST TIME SHE WAS HOSPITALIZED, AND THEN THE DOCTOR ORDERED HER TO STOP USING THE DEVICE TO ALLOW HER SKIN TO HEAL. THE CUSTOMER MENTIONED THAT SHE LOST THE BATTERY CAP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353140 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 22 YR Hospitalization