BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974383 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89091
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP IS SQUIRTING OUT INSULIN. CUSTOMER STATED THEY WERE WORRIED THAT THE INSULIN PUMP MAY BE OVER DELIVERING INSULIN, SINCE THE QUANTITY IN THE RESERVOIR HAS LOWERED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL DROPPED SIGNIFICANTLY. DURING THE CALL THE CUSTOMER SOUNDED CONFUSED, TREATED WITH JUICE. CUSTOMER NOTICED THE INSULIN PUMP WAS OVER DELIVERING INSULIN WHEN SHE GOT THE EPUMP. ADVISED CUSTOMER TO DISCONTINUE THE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE BLOOD GLUCOSE READING WAS 104MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451220 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1