BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3211974 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-95484
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 CHANGED THE INFUSION SET AND APPROXIMATELY ELEVEN MINUTES LATER HIS GLUCOSE LEVEL WAS 183MG/DL. THE CUSTOMER WENT TO SLEEP AND HE WAS FOUND UNRESPONSIVE AND SWEATING HOURS LATER. HIS BLOOD GLUCOSE WAS 19MG/DL AND THEY GAVE HIM SODA, BUT HE DID NOT REACT AND THE PARAMEDICS WERE CALLED AND TREATED HIM. THE CUSTOMER STILL DID NOT REACT AND HE WAS TAKEN TO THE HOSPITAL. IT WAS STATED THAT THE CUSTOMER FILLED THE RESERVOIR WITH 140.0 UNITS OF INSULIN AND THE ENTIRE RESERVOIR EMPTIED INTO HIS BODY. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308570 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization