BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3951360 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-88074
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 398 MG/DL. THE STATED THAT 4 DAYS PRIOR TO THE HOSPITALIZATION, THEIR BLOOD GLUCOSE FLUCTUATED BETWEEN 40 MG/DL TO 70 MG/DL. THEY HAD SHORTNESS OF BREATH, NAUSEA, FATIGUE, AND SEVERE HEADACHE. THEY WERE TREATED WITH THE INSULIN PUMP AND MANUAL INJECTION. THE DAY BEFORE BEING RELEASED FROM THE HOSPITAL THE CUSTOMER RECONNECTED TO THE DEVICE. THEIR DIABETES EDUCATOR CAME AND INCREASED THE BASAL RATE TO 1.5 UNITS. THE CUSTOMER STATED THEY HAVE OTHER MEDICAL ISSUES. THEIR OXYGEN LEVEL WAS EXTREMELY LOW AND THEY HAD SMALL AMOUNT OF KETONES SPILLING INTO THEIR BLOOD AND THEY WERE IN BEGINNING STAGES OF DIABETIC KETOACIDOSIS. DURING TROUBLESHOOTING THE BOLUS HISTORY JUMPED FROM (B)(6), THE PRIME WAS 6-7 DAYS, BUT THE CUSTOMER STATED THEY CHANGE EVERY 3-4 DAYS. FILL CANNULA WAS SET TO 0.4 UNITS INSTEAD OF 0.5 UNITS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428446 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization