BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4790944 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58538
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 2, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE HAD HIGH BLOOD GLUCOSE OF 391 MG/DL AT THE TIME. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 216 MG/DL. CUSTOMER TREATED FOR A CORRECTION WHILE EATING TOAST BUT DID NOT TREAT FOR HER BLOOD GLUCOSE. CUSTOMER STATED THAT SHE HAD A HEADACHE. CUSTOMER STATED THAT THE PARAMEDICS DID NOT MEDICALLY TREAT HER BUT THEY CHECKED HER VITALS AND CONTACTED HER HEALTH CARE PROFESSIONAL. CUSTOMER PERFORMED A HIGH PRESSURE TEST AND THE PUMP DELIVERED. CUSTOMER WAS ADVISED TO DO A COMPLETE SET CHANGE. CUSTOMER WILL MONITOR THE PUMP. CUSTOMER CALLED BACK AND STATED THAT SHE WENT TO THE EMERGENCY ROOM. CUSTOMER HAD TROUBLE WITH A KINKED INFUSION SET AND HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 514 MG/DL. CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR, AND INSULIN. CUSTOMER WAS EXPERIENCING CHEST PAIN. CUSTOMER'S HUSBAND OFFERED TO DRIVE THE CUSTOMER TO THE EMERGENCY ROOM. CUSTOMER IS NOT CURRENTLY WEARING THE PUMP. CUSTOMER THEN HUNG UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335066 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR