BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3951366 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-88091
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 15, 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
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 687 MG/DL. THE NURSE AT THEIR DOCTOR'S OFFICE ADVISED THE CUSTOMER TO GO TO THE EMERGENCY ROOM. WHILE IN THE HOSPITAL, THE CUSTOMER REMOVED THE RESERVOIR FROM THE INSULIN PUMP AND INSULIN SPILLED ON THEM. THE CUSTOMER WAS NOT GETTING INSULIN DELIVERED. THEY WERE TREATED WITH AT MANUAL INJECTION AT THE HOSPITAL. THE CUSTOMER HAD NAUSEA, HEADACHE, AND BLURRED VISION AND WAS FEELING WEIRD. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE EMERGENCY ROOM VISIT. THE DRIVE SUPPORT CAP WAS RECESSED, FOUND SMALL BUBBLES IN THE TUBING BUT NOT IN THE RESERVOIR. THE SETTINGS OF THE DEVICE WERE CORRECT. FOUND EXCESSIVE NO DELIVERY ALARMS IN THE HISTORY OF THE DEVICE. THE CANNULA WAS NOT BENT OR OCCLUDED. THE CUSTOMER STATED THAT THE LEAK WAS PAST THE 2ND O-RING, INSIDE THE RESERVOIR COMPARTMENT AND THAT THE RESERVOIR WAS USED. THE ALARM WAS RESOLVED BY INFUSION SET CHANGE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428448 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization