BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3984527 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-90357
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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 BY THE CUSTOMER THAT THEY HAD BEEN HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. CUSTOMER WAS DISCONNECTED FROM INSULIN PUMP AND WAS GIVEN MANUAL INSULIN INJECTIONS DURING HOSPITALIZATION. BLOOD GLUCOSE LEVEL WAS OVER 500 MG/DL AT TIME OF HOSPITALIZATION. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO CHECK THE CONDITION OF THE DRIVE SUPPORT CAP ON THE DEVICE AND FOUND IT TO BE NORMAL. NEXT, CUSTOMER WAS ASKED TO CHECK FOR AIR BUBBLES IN INFUSION SET TUBING. CUSTOMER VERIFIED THERE WERE AIR BUBBLES IN INFUSION SET TUBING. AFTERWARDS, RESERVOIR WAS REINSERTED INTO INSULIN PUMP AND A MANUAL PRIME WAS PERFORMED. DEVICE DID NOT ALARM AND WAS FOUND TO BE FUNCTIONING PROPERLY. ADVISED CUSTOMER TO MONITOR DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459540 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization