BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4133211 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-30934
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 IS REPORTED THAT A CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE OF 21 MG/DL. THE CUSTOMER WAS WOKEN UP BY MEDICS AND WAS TRANSFERRED TO THE HOSPITAL WHERE SHE WAS TREATED. THE CUSTOMER WAS INFORMED THAT THERE COULD BE MANY REASONS FOR LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT SOMETHING WAS WRONG WITH THE PUMP AND WANTED TO TROUBLE SHOOT BUT STATED THAT THEY WOULD CALL BACK IN AN HOUR OR SO TO DO SO. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610987 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR