BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3230548 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-95762
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    January 9, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 WITH HIGH BLOOD GLUCOSE OVER 400MG/DL, AND THE INSULIN PUMP WAS MALFUNCTIONING. THE MOTHER STATED THAT THE CUSTOMER HAD BENT CANNULAS AND HAD REPORTED THIS ISSUE BEFORE SEVERAL TIMES. THE MOTHER STATED THAT THE CAUSE OF HER ADMISSION WAS HIGH BLOOD PRESSURE AND DEHYDRATION. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. FURTHER TESTING COULD NOT BE PERFORMED AS CUSTOMER STATED THAT THE INSULIN PUMP SEEMS TO BE FUNCTIONING PROPERLY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329477 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 19 YR Hospitalization