BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4771021 · Received May 14, 2015

    Report

    Report Number
    2032227-2015-15652
    Event Type
    Injury
    Date Received
    May 14, 2015
    Date of Event
    March 9, 2015
    Report Date
    April 22, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 VIA PHONE CALL THAT THE CUSTOMER WAS TREATED BY PARAMEDICS, AFTER HIS BLOOD GLUCOSE WENT DOWN TO 27 MG/DL. WHEN PARAMEDICS ARRIVED, HIS BLOOD GLUCOSE WAS 29 MG/DL AND HE WAS TREATED WITH FOOD AND A GLUCAGON SHOT. CALLER SAID THEY SPOKE WITH A NURSE WHO CHANGED SOME SETTINGS, BUT IT DID NOT HELP WITH LOW BLOOD GLUCOSE ISSUES. AT TIME OF THE CALL, CUSTOMER'S BLOOD GLUCOSE WAS 170 MG/DL. THE CUSTOMER WAS ASLEEP AND CALLER DID NOT WISH TO WAKE HIM UP TO FINISH TROUBLESHOOTING. IT WAS ADVISED TO CALL BACK TO TROUBLESHOOT WHEN CUSTOMER AND INSULIN PUMP WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317001 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR