BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4212442 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-38940
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A BLOOD GLUCOSE READING OF 400 MG/DL. SHE RECEIVED A NO DELIVERY ALARM AND A LOW BATTERY ALARM AND SHE SHUT HER PUMP OFF WITHOUT REVERTING TO A BACK-UP PLAN. STANDARD TROUBLESHOOTING WAS PERFORMED FOR BOTH ALARMS. THE NO DELIVERY ALARM WAS RESOLVED BY AN INSULIN INFUSION SET CHANGE. THE LOW BATTERY ALARM WAS RESOLVED WITH A BATTERY CHANGE. THE INSULIN INFUSION SET AND THE RESERVOIR ARE NOT BEING RETURNED BECAUSE THEY WERE DISPOSED OF. THE PRODUCT IS NOT BEING RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680617 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other