BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4212446 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43290
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S MOTHER IS ON THE LINE AND SHE STATED THAT HER SON PASSED OUT WHILE AT SCHOOL WITH A LOW BLOOD GLUCOSE LEVEL OF 38 MG/DL. CUSTOMER'S MOTHER STATED THAT HER SON WAS IN THE NURSE'S OFFICE AT THE TIME OF THE EVENT. CUSTOMER'S MOTHER REPORTED THAT THE AMBULANCE WAS CALLED AND GLUCAGON WAS ADMINISTERED. CUSTOMER'S MOTHER STATED THAT ENDOCRINOLOGIST TOLD THEM NOT TO TAKE HIM TO THE EMERGENCY ROOM. CUSTOMER WAS TREATED WITH GLUCAGON. CUSTOMER HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS FOR THE PAST THREE DAYS. CUSTOMER'S BLOOD GLUCOSE LEVEL HAS BEEN DROPPING LOW BUT NOT AS LOW. CUSTOMER'S MOST RECENT SET CHANGE WAS (B)(6) 2014. CUSTOMER WAS DISCONNECTED DURING THE REWIND/PRIME SEQUENCE. CUSTOMER WAS NOT ADMITTED AS AN INPATIENT FOR MEDICAL TREATMENT. CUSTOMER WAS ADVISED TO MONITOR THE PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680909 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR