BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3854989 · Received June 9, 2014

    Report

    Report Number
    2032227-2014-02960
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS FOUND PASSED OUT AND WAS TAKEN TO THE HOSPITAL, DUE TO LOW BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 38 MG/DL. THE CUSTOMER REPORTS THAT THE CAUSE OF HER LOW BLOOD GLUCOSE WAS A BOLUS DELIVERED BY HER INSULIN PUMP THAT SHE DID NOT RECALL ADMINISTERING. THE PATIENT WAS TREATED WITH INTRAVENOUS DEXTROSE AND STATES THIS WAS AN ISOLATED ISSUE. THE CURRENT BLOOD GLUCOSE READING IS 141 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334659 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization