BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5621939 · Received April 29, 2016

    Report

    Report Number
    3004209178-2016-40719
    Event Type
    Injury
    Date Received
    April 29, 2016
    Date of Event
    April 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 SHE HAD HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT SHE CHANGED HER INFUSION SET 3 TIMES AND WAS STILL RECEIVING HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT LAST NIGHT, HER BLOOD GLUCOSE GOT UP TO 546 MG/DL. CUSTOMER REMOVED THE PUMP AND CONTACTED HER HEALTH CARE PROFESSIONAL. CUSTOMER HAS BEEN ON A BACK-UP PLAN SINCE YESTERDAY. CUSTOMER'S BLOOD GLUCOSE IS 160 MG/DL. CUSTOMER DOES NOT FEEL GOOD AND DOES NOT HAVE AN APPETITE. CUSTOMER TREATED FOR HIGH BLOOD GLUCOSE WITH A MANUAL INJECTION. CUSTOMER STATED THAT SHE REMOVED THE BATTERY FROM THE PUMP AND DOES NOT HAVE ANY BATTERIES TO PUT INTO THE PUMP. CUSTOMER WAS ADVISED TO GET A BATTERY AND CALL BACK TO TROUBLESHOOT. CUSTOMER STATED THAT SHE WILL CALL BACK ONCE SHE BUYS NEW BATTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274180 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other