BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3222983 · Received July 12, 2013

    Report

    Report Number
    2032227-2013-02894
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 STATED THAT SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE OF 680 MG/DL. THE CUSTOMER STATED THAT SHE HAD GIVEN HERSELF A BOLUS PRIOR TO THE EVENT, BUT HER BLOOD GLUCOSE LEVELS DID NOT COME DOWN. THE CUSTOMER FELT THAT THE INSULIN PUMP WAS NOT WORKING PROPERLY, AND STOPPED USING IT. THE CUSTOMER STATED THAT SHE IS NOW IN MANUAL INJECTIONS. OFFERED TO TROUBLESHOOT, BUT THE CUSTOMER DECLINED AS SHE IS NO LONGER ON INSULIN PUMP THERAPY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322207 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization