BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4182595 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39849
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING HOSPITALIZED ON (B)(6) 2014 FOR DIABETIC KETOACIDOSIS. CUSTOMER'S BLOOD GLUCOSE WAS 522 MG/DL WHEN ADMITTED. SHE EXPERIENCED NAUSEA, DEHYDRATION, BLURRED VISION, AND HIGH KETONES. LEADING UP TO THE EVENT, CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS THAT WOULD NOT GO DOWN. AFTER A DAY, CUSTOMER WENT TO THE EMERGENCY ROOM. CUSTOMER WAS ON SOME TREATMENT THAT KEPT HIS BLOOD GLUCOSE UP. HE WAS TREATED WITH TWO BAGS OF FLUID AND INSULIN THROUGH AN IV. HIS BLOOD GLUCOSE WAS 78 MG/DL WHEN RELEASED. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660725 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization