BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4181422 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39665
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 HAD SEVERAL NO DELIVERY ALARMS SINCE (B)(6) 2014. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 403 MG/DL. CUSTOMER STATED THAT SHE TREATED WITH A BOLUS. CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS ARE HIGH BECAUSE SHE WENT FROM 12:03 AM UNTIL GETTING UP TO ADDRESS THE NO DELIVERY ALARM. CUSTOMER REPORTED THAT THE ALARM WAS RESOLVED BY AN INFUSION SET CHANGE. CUSTOMER WAS UNABLE TO TROUBLESHOOT BECAUSE SHE CHANGED HER SET BEFORE CALLING. CUSTOMER DOES NOT WANT TO RETURN THE SET OR RESERVOIR FOR ANALYSIS. CUSTOMER STATED THAT THE PUMP IS TAKING A LONGER TIME TO PRIME, BUT SHE IS SEEING THE DROPS AT THE END OF THE TUBING. CUSTOMER IS NOT GETTING ANY ALARMS. THERE ARE NO ISSUES WITH THE PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660517 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR