BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4251407 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52664
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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 WAS HOSPITALIZED ON (B)(6) 2014 FOR HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING AT THE TIME OF THE EMERGENCY ROOM VISIT WAS 378 MG/DL. THE CUSTOMER HAD BEEN TREATING WITH THE INSULIN PUMP BUT HER BLOOD GLUCOSE LEVELS DID NOT GO DOWN. CUSTOMER WAS NOT TREATED WITH INSULIN AT THE HOSPITAL. THE CUSTOMER WAS MONITORED AND TREATED WITH A BAG OF SALINE. THE INSULIN PUMP WAS BEING WORN BY THE CUSTOMER AT THE TIME OF THE HOSPITALIZATION. THE CUSTOMER DECLINED TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738166 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization