BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4132411 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31245
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    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

    CUSTOMER REPORTED SHE HAS BEEN HAVING LOW BLOOD GLUCOSE LATELY. THIS MORNING SHE WAS FINE, BUT THEN IT DROPPED TO 52 MG/DL. SHE TREATED WITH THREE GLUCOSE TABLETS, BUT FELT SHE WAS STILL GOING LOW. SHE ATE BREAKFAST AND HER BLOOD GLUCOSE WAS 105 MG/DL. SHE STILL FELT GROGGY, SO HER HUSBAND CALLED THE PARAMEDICS. WHEN THEY CHECKED HER BLOOD GLUCOSE, IT WAS 20 MG/DL. SHE WAS TREATED WITH SUGAR AND TAKEN TO THE EMERGENCY ROOM. CUSTOMER WAS FEELING FOGGY AND UNCONSCIOUS. CUSTOMER IS BACK HOME NOW. SHE WAS ADVISED TO SPEAK TO HER DOCTOR ABOUT ADJUSTING HER SETTINGS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613048 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization