BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4161929 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36126
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 11, 2014
    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
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE WAS HOSPITALIZED DUE TO A KINK IN HER INFUSION SET. DATE OF HOSPITALIZATION WAS (B)(6) 2014. BLOOD GLUCOSE AT THE TIME OF HOSPITALIZATION WAS 473 MG/DL. SHE STATED SHE WAS VOMITING SEVERELY AND WAS FEELING LOW ON ENERGY PRIOR TO HER HOSPITALIZATION. SHE ALSO REPORTED THE EMERGENCY MEDICAL SERVICES WAS CALLED AND THEY HAD TREATED HER WITH INSULIN. CUSTOMER ALSO STATED THE EMERGENCY RESPONDERS HAD TAKEN HER OFF THE INSULIN PUMP IN ORDER TO TREAT HER BLOOD GLUCOSE. THE CUSTOMER ALSO STATED SHE WAS HOSPITALIZED DUE TO HAVING DIABETES KETOACIDOSIS. THE CUSTOMER WAS TREATED WITH AN IV AND WAS SENT HOME WITH NOVOLOG AND LANTUS IN ADDITION TO SYRINGES. THE CUSTOMER STATED THIS WAS THE THIRD TIME SHE HAD THIS ISSUE. SHE ALSO REPORTED SHE WAS PREVIOUSLY HOSPITALIZED FOR DIABETES KETOACIDOSIS FOR THE SAME ISSUE WITH HER INFUSION SET. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644810 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization