BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4190428 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-27033
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING LOW RESERVOIR. CUSTOMER STATED THEY HAD TOE SURGERY PERFORMED AND WERE REMISS ON HOW TO PRIME THE DEVICE. BLOOD GLUCOSE LEVEL WAS 181 MG/DL AT TIME OF REPORTING AND HAD NOT BEEN RELEASED FROM THE HOSPITAL. THE CUSTOMER WAS ASSISTED WITH INSTRUCTIONS ON PERFORMING A SAFE REWIND/PRIME. HOSPITAL NURSE INTERVENED AND STATED DEVICE WAS CONTINUOUSLY ALARMING. ASSISTED HOSPITAL NURSE WITH CLEARING ALARM AND RESOLVING THE ISSUE IN THE FUTURE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667407 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization