BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3200305 · Received July 1, 2013

    Report

    Report Number
    2032227-2013-02685
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 INSULIN PUMP WAS GIVING A BATTERY OUT LIMIT ALARM. THE CALLER ALSO STATED THAT THE CUSTOMER WAS IN THE HOSPITAL, BUT DID NOT GIVE THE REASON. THE CUSTOMER LATER CALLED TO REPORT THAT THE HOSPITALIZATION WAS DUE TO A HIGH BLOOD GLUCOSE OF 730 MG/DL. THE CUSTOMER WAS TOLD BY HIS HCP THAT THE EVENT MAY HAVE BEEN DUE TO AN INFECTION AS HE ALSO HAD THE FLU. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298507 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization