BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183079 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40032
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 19, 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

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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

    WHILE RECEIVING ASSISTANCE WITH PROGRAMMING THE INSULIN PUMP, CUSTOMER REPORTED THAT HE WAS RECENTLY HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. CUSTOMER REPORTED THAT PARAMEDICS RESPONDED TO A CALL REGARDING HIS HIGH BLOOD GLUCOSE LEVEL, AND HE WAS LATER ADMITTED TO THE HOSPITAL. BLOOD GLUCOSE LEVEL AT THE TIME OF PARAMEDICS' RESPONSE WAS 500 MG/DL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS NOT PROVIDED. CUSTOMER WAS NOT ON AN INSULIN PUMP WHILE HOSPITALIZED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660444 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization