BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4973147 · Received August 5, 2015

    Report

    Report Number
    2032227-2015-25324
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    May 14, 2015
    Report Date
    July 14, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED ON (B)(6) 2015 FOR HIGH BLOOD GLUCOSE. CUSTOMER STATED THEIR BLOOD GLUCOSE WAS 500 MG/DL AT THE TIME OF HOSPITALIZATION. IT WAS FOUND THE CUSTOMER WAS FEELING TIRED, THIRSTY AND HAD SHORTNESS OF BREATH. THE CUSTOMER REPORTED THE CAUSE OF THEIR HOSPITALIZATION WAS FROM DIABETIC KETOACIDOSIS. CUSTOMER WAS HOSPITALIZED FOR ONE WEEK AS A RESULT. THE CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 301 MG/DL. THE CUSTOMER TREATED THEIR BLOOD GLUCOSE WITH A BOLUS. TROUBLESHOOTING DID NOT FIND ANY LEAKS OR AIR BUBBLES PRESENT ON THE INSULIN PUMP. THE CUSTOMER WAS UNABLE TO PERFORM A HIGH PRESSURE TEST AT THE TIME OF THE CALL. CUSTOMER WAS ADVISED TO CHANGE OUT THEIR ENTIRE INFUSION SET, RESERVOIR, AND INSULIN. THE CUSTOMER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513246 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization