BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210561 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43282
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 CONCLUSIONS CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A B BLOOD GLUCOSE READING OF 36 MG/DL. HER METER SHOWED BLOOD GLUCOSE LEVELS IN THE 120'S MG/DL, BUT SHORTLY AFTER HER LEVELS WERE IN THE 30'S MG/DL. SHE HAD TO CALL EMERGENCY MEDICAL TECHNICIANS FOR ER LOW BLOOD GLUCOSE OF 36MG/DL SHE WAS NOT HOSPITALIZED AND HER BLOOD GLUCOSE LEVELS ROSE TO 58 MG/DL, BY THE TIME EMERGENCY MEDICAL ARRIVED THE CUSTOMER BELIEVES THE ISSUE OCCURRED BECAUSE OF THE PROGRAMMED BASAL RATE SETTING ON HER INSULIN PUMP. THE PRODUCT IS NOT BEING RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680354 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other