BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3200282 · Received July 1, 2013

    Report

    Report Number
    2032227-2013-02676
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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

    THE CUSTOMER CALLED FOR ASSISTANCE AFTER CHANGING THE RESERVOIR. FOUND THAT THE CUSTOMER MAY HAVE PRIMED THE INSULIN PUMP WHILE SHE WAS CONNECTED TO THE INFUSION SET. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE DROPPING QUICKLY, AND THE PARAMEDICS WERE CALLED TO HER HOME FOR ASSISTANCE AS SHE WAS NOT FEELING WELL. THE PARAMEDICS ARRIVED, AND CONFIRMED THAT THERE WAS ONLY 0.5 ML OF INSULIN LEFT IN THE RESERVOIR. THE PARAMEDICS CHECKED HER BLOOD GLUCOSE AND IT WAS 155 MG/DL, UP FROM 138 MG/DL. THE CUSTOMER'S DAUGHTER GOT HOME, AND STATED THAT SHE HAD PRE-FILLED THE RESERVOIR FOR HER BECAUSE OF HER DEXTERITY ISSUES. ADVISED THE DAUGHTER THAT HER MOTHER PRIMED WHILE SHE WAS CONNECTED. ADVISED HER OF THE PROPER TECHNIQUE, AND SHE UNDERSTOOD. THE DAUGHTER STATED THAT THIS WAS HER FIRST TIME CHANGING THE INFUSION SER ON HER OWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298653 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention