BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233513 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48913
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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 THAT THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014 AROUND 9 AM FOR A BLOOD GLUCOSE LEVEL OF 370 MG/DL AND DIABETES KETOACIDOSIS. THE CUSTOMER EXPERIENCED VOMITING AS A SYMPTOM OF HER HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION. AT THE HOSPITAL, SHE WAS TREATED WITH AN INSULIN DRIP. SHE STATED SHE WAS USING A DIFFERENT TYPE OF INSULIN. STANDARD TROUBLESHOOTING WAS PERFORMED ON THE INSULIN PUMP BUT WAS UNABLE TO BE COMPLETED. THE CUSTOMER WAS ADVISED TO CHANGE HER INFUSION SET, RESERVOIR, AND INSULIN. THE PRODUCT IS NOT BEING RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713210 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization