BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2082636 · Received April 27, 2011

    Report

    Report Number
    3004209178-2011-81231
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    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 FOR HIGH BLOOD GLUCOSE OF 400 MG/DL. THE CUSTOMER STATED THAT SHE CHANGES THE INFUSION SET AND RESERVOIR EVERY SIX TO EIGHT DAYS. TROUBLESHOOTING WAS PERFORMED. THE TIME WAS ONE HOUR OFF. IT WAS STATED THAT THE CUSTOMER ATE BUT SHE DID NOT TAKE INSULIN. REVIEWED THE DAILY TOTALS AND FOUND THAT THE TOTALS ONLY CORRESPONDED TO THE BASAL RATES. ALSO, IT WAS FOUND THAT THE DAILY TOTALS HAD ONLY BEEN FOR HER BASAL RATES AND SHE DOES NOT KNOW HOW TO USE THE BOLUS WIZARD. THE CUSTOMER STATED THAT SHE TAKES 20 UNITS OF INSULIN IN THE MORNING, 15 UNITS FOR LUNCH, AND 15 UNITS FOR DINNER MANUALLY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization