BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3200580 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-95288
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 IN THE EMERGENCY ROOM DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 371MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HE HAD AN UPPER RESPIRATORY ISSUE AND HIS DOCTOR GAVE HIM SOME ANTIBIOTICS AND WENT HOME, BUT WHEN HE WOKE UP HE FELT VERY SICK AND WENT TO THE HOSPITAL. THE CALLER STATED ALSO THAT THEY GAVE HIM ATIVAN MEDICATION TO CALM HIM DOWN. THE CUSTOMER MENTIONED THAT THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298487 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization