BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4823094 · Received June 6, 2015

    Report

    Report Number
    3004209178-2015-63318
    Event Type
    Injury
    Date Received
    June 6, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE CUSTOMER CALLED AND REPORTED THE INSULIN PUMP ALARMED WITH MOTOR ERROR AND GAVE NO DELIVERY ALARMS DURING BOLUS DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 499 MG/DL, WHICH WAS TREATED WITH MANUAL INJECTION. CUSTOMER STATED HE WAS AT WORK AND COULD NOT CHANGE THE SET TO COMPLETE TROUBLESHOOTING. CUSTOMER WAS STILL RECEIVING THE NO DELIVERY ALARM AND STATED WHEN HE WOULD DISCONNECT, INSULIN WOULD COME OUT. CUSTOMER WAS ADVISED TO CHANGE SET AS SOON AS POSSIBLE. CUSTOMER STATED HE WOULD CALL BACK WHEN HE WAS TO ARRIVE HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366878 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 56 YR