BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4193637 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41333
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A MOTOR ERROR ALARM ON HER INSULIN PUMP. CUSTOMER CALLED BECAUSE, SHE HAD UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS AND HAD TO GO TO THE EMERGENCY ROOM. CUSTOMER RECEIVED IV AND INSULIN THERAPY. CUSTOMER SAW HER HEALTH CARE PROFESSIONAL YESTERDAY AND THEY INCREASED BASAL AND LOWERED CARB RATION. CUSTOMER'S LOWEST BLOOD GLUCOSE LEVEL WAS 198 MG/DL THIS MORNING. CUSTOMER HAS BEEN ON THE PUMP FOR 8 YEARS. CUSTOMER WENT TO THE HOSPITAL ON (B)(6) 2014. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL AT THE TIME OF HOSPITAL VISIT. CUSTOMER HAD SUBWAY FOR LUNCH AND THEN HER BLOOD GLUCOSE LEVEL WENT SKY HIGH. CUSTOMER WAS NOT ADMITTED BUT HAD SAME DAY TREATMENT. CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE EMERGENCY ROOM VISIT. CUSTOMER HAD A LOW RESERVOIR AND A LOW BATTERY ALARM IN THE ALARM HISTORY. CUSTOMER DOES NOT HAVE A TUBING CLAMP. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671462 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization