BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920039 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86525
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    CUSTOMER REPORTED A HOSPITALIZATION FOR HIGH BLOOD GLUCOSE LEVELS. SHE STATED SHE STARTED RECEIVING NO DELIVERY ALARMS AND HER BLOOD GLUCOSE LEVEL BEGAN TO RISE. CUSTOMER WENT TO THE EMERGENCY ROOM FOR HIGH BLOOD GLUCOSE AND DEHYDRATION. HER BLOOD GLUCOSE LEVEL AT THE TIME OF ADMISSION WAS OVER 400 MG/DL. CUSTOMER WAS TREATED WITH INSULIN AND A SALINE IV. AFTER RETURNING HOME FROM THE HOSPITAL, CUSTOMER REPORTED STILL EXPERIENCING HIGH BLOOD GLUCOSE LEVELS AND NO DELIVERY ALARMS. CUSTOMER CALLED HER DOCTOR AND TREATED WITH MANUAL INJECTION. HER BLOOD GLUCOSE LEVEL IS 307 MG/DL. DURING TROUBLE SHOOTING, CUSTOMER STATED THE DRIVE SUPPORT CAP APPEARED NORMAL. INSULIN EXITED THE TUBING DURING MANUAL PRIME. SEVERAL NO DELIVERY ALARMS WERE CONFIRMED IN THE DEVICE HISTORY. TROUBLE SHOOTING COULD NOT BE COMPLETED DUE TO LACK OF TUBING CLAMPS. CUSTOMER REPORTED THE ISSUE WAS RESOLVED WITH A COMPLETE INFUSION SET CHANGE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396604 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization