BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4181399 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39655
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    June 8, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 WENT TO THE HOSPITAL ON (B)(6) 2014 IN THE EVENING FOR HIGH BLOOD GLUCOSE LEVELS. CUSTOMER'S SISTER STATED THAT THE CUSTOMER HAD A MALFUNCTION BUT SHE WAS UNSURE OF WHAT IT WAS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS SO HIGH THAT THE PARAMEDICS WERE CALLED AND HE WAS TAKEN TO THE HOSPITAL. CUSTOMER WAS DISCHARGED ON (B)(6) 2014 AND WENT TO A SKILLED NURSING FACILITY ON (B)(6) 2014. IT IS UNSURE IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE HOSPITALIZATION. CUSTOMER WAS OFF THE PUMP PRIOR TO HOSPITALIZATION. CUSTOMER'S SISTER THINKS THERE WAS AN ISSUE WITH THE CONNECTION BUT SHE IS UNSURE. CUSTOMER'S SISTER REPORTED THAT HER BROTHER WAS UNABLE TO TALK BECAUSE HE WAS IN THE HOSPITAL FOR A NON-DIABETES RELATED ISSUE. CUSTOMER IS NOT ON THE PUMP RIGHT NOW AND WAS ADVISED TO REMAIN OFF THE PUMP RIGHT NOW UNTIL THE MALFUNCTION CAN BE FOUND. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660446 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization