BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5981742 · Received September 27, 2016

    Report

    Report Number
    2032227-2016-24374
    Event Type
    Injury
    Date Received
    September 27, 2016
    Date of Event
    July 19, 2016
    Report Date
    September 6, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER NOTICED INFUSION SET LEAKS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 451 MG/DL. THE CUSTOMER NOTICED LEAKING AROUND THE INFUSION SET ADHESIVE. HER BLOOD GLUCOSE LEVEL WAS HIGH BECAUSE SHE WAS NOT RECEIVING INSULIN. SHE TREATED HER HIGH BLOOD GLUCOSE LEVELS WITH BOLUSES. THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633583 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other