BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210484 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43481
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IS IT 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 HAD HIGH BLOOD GLUCOSE LEVELS OF OVER 600 MG/DL. THE CUSTOMER REPORTED BEING HOSPITALIZED ON (B)(6) 2014. THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS AND DIABETES KETOACIDOSIS. THE CUSTOMER INDICATED HAVING SYMPTOMS CONSISTENT WITH HIGH BLOOD GLUCOSE LEVELS INCLUDING VOMITING AND NAUSEA. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION. THE CUSTOMER ALSO REPORTED SMELLING INSULIN FROM THE OUTSIDE OF THE BATTERY COMPARTMENT OF THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED A CRACK ON THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680414 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization