BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5130606 · Received October 6, 2015

    Report

    Report Number
    2032227-2015-53772
    Event Type
    Injury
    Date Received
    October 6, 2015
    Date of Event
    September 19, 2015
    Report Date
    September 20, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAVE EXPERIENCED HIGH BLOOD GLUCOSE OF 450 MG/DL AND WOULD LIKE TO TROUBLESHOOT PUMP TO MAKE SURE EVERYTHING IS WORKING FINE. TROUBLESHOOTING FOUND THAT THE CUSTOMER'S DRIVE SUPPORT CAP WAS NORMAL BUT THAT THE CANNULA WAS BENT. CUSTOMER DECLINED ANY FURTHER TROUBLESHOOTING. DURING THE CALL, CUSTOMER'S BLOOD GLUCOSE WENT TO 374 MG/DL. TROUBLESHOOTING INDICATED THAT THE DEVICE WAS PERFORMING AS DESIGNED AND DECLINED TO SEND PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660043 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other