BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4042726 · Received August 27, 2014

    Report

    Report Number
    3004209178-2014-99700
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 BY THE CUSTOMER THAT THEY HAD BEEN HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS ON (B)(6) 2014. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 254 MG/DL PRIOR TO SEEKING HOSPITALIZATION AND 583 MG/DL AT TIME OF HOSPITALIZATION. CUSTOMER TREATED HIGH BLOOD GLUCOSE LEVELS WITH 11.8 UNITS OF INSULIN. DURING TROUBLESHOOTING, CUSTOMER FOUND THE CANNULA WAS BENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520132 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization