BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2090168 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81377
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 30, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DIABETES KETOACIDOSIS, HIGH BLOOD GLUCOSE, AND DEHYDRATION. THE BLOOD GLUCOSE READING WAS 756MG/DL. THE CUSTOMER STATED HER STRESS LEVEL WAS ELEVATED. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING ON THE INSULIN WAS CORRECT. REVIEWED THE STATUS SCREEN AND THE CUSTOMER WAS ON TEMPORARY BASAL. CHECKED THE BASALS AND IT APPEARS THAT THE CUSTOMER ERASED THE BASALS. ADVISED THE CUSTOMER THAT SHE IS NOT GETTING ANY BASAL DELIVERY AT THIS TIME, WHICH COULD BE WHY SHE CANNOT CONTROL HER GLUCOSE LEVEL. THE CUSTOMER STATED THAT SHE MAY HAVE ACCIDENTALLY ERASED THE BASAL SETTINGS, BUT SHE WILL CONTACT HER DOCTOR. NO FURTHER INFO 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-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization (B)(4) INFUSION QUICK-SET PARADIGM 23", 9MM,| MMT-397