BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3200283 · Received July 1, 2013

    Report

    Report Number
    2032227-2013-02682
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    February 1, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 CALLED TO REPORT THAT SHE'S BEEN GETTING NO DELIVERY ALARMS FOR THE PAST MONTH AND A HALF. THE CUSTOMER THEN STATED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS BACK IN FEBRUARY, AND HER DOCTOR DIDN'T KNOW WHAT WAS CAUSING HER ELEVATED BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT WHEN SHE EXPERIENCES HIGH BLOOD GLUCOSE LEVELS, SHE EATS, THEN HER BLOOD GLUCOSE LEVELS DROP. THE CUSTOMER DID NOT WANT TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVELS AT THE TIME OF THE CALL. ADVISED THE CUSTOMER TO CALL BACK AT ANY TIME FOR TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299881 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization