BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3230530 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-95769
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 REPORTED BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 209MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE CUSTOMER STATED THAT SHE WAS IN HER DOCTOR'S OFFICE WHEN HER BLOOD GLUCOSE DROPPED TO 21MG/DL AND HAD A SEIZURE; THEN THE CUSTOMER WAS SENT TO THE HOSPITAL. THE CALLER MENTIONED THAT SHE DOUBLED THE BASAL RATES STARTING AT MIDNIGHT A COUPLE DAYS AGO. REVIEWED THE PROGRAMMING, AND THE RESERVOIR WAS SHOWING MORE INSULIN THAN WHAT IT WAS SHOWING ON THE STATUS SCREEN. THE CUSTOMER STATED THAT SHE HAS BEEN SICK WITH KIDNEY INFECTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329404 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization