BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5001823 · Received August 13, 2015

    Report

    Report Number
    2032227-2015-29129
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    February 23, 2015
    Report Date
    March 2, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HER BLOOD GLUCOSE WAS IN THE 60'S MG/DL TODAY. CUSTOMER STATED THAT SHE HAS BEEN HAVING LOW BLOOD GLUCOSE FOR ABOUT A WEEK. CUSTOMER STATED THAT HER SENSOR READING WAS 67 MG/DL AND HER BLOOD GLUCOSE WAS 64 MG/DL. IT WAS REPORTED THAT THE CUSTOMER HAD A LOW BLOOD GLUCOSE OF 33 MG/DL. CUSTOMER STATED THAT SHE IS DRINKING SOME MILK TO BRING UP HER BLOOD GLUCOSE. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS RECOMMENDED TO SPEAK WITH HER HEALTH CARE PROFESSIONAL ABOUT POSSIBLY REDUCING HER BASAL RATES. CUSTOMER STATED THAT LAST WEEK SHE FELL OUT OF THE SHOWER BACKWARDS AND SHE WAS NOT SURE IF THAT MESSED HER UP SOMEHOW. CUSTOMER WENT TO THE HOSPITAL DUE TO FALLING OUT OF THE SHOWER AND WAS INFORMED THAT HER BLOOD GLUCOSE WAS FINE. CUSTOMER CHECKED HER BLOOD GLUCOSE AND IT WAS 73 MG/DL AFTER 16.5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534233 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other