BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6148437 · Received December 6, 2016

    Report

    Report Number
    2032227-2016-47306
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    October 24, 2016
    Report Date
    November 7, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 600 MG/DL. THE CUSTOMER NO SYMPTOMS. CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH INSULIN PEN. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 52 AT THE TIME OF THE CALL, DUE TO BEING OFF OF INSULIN PUMP AS REQUESTED BY PHYSICIAN SINCE (B)(6) 2016. CUSTOMER REPORTED THAT THE HIGH BLOOD GLUCOSE LEVELS BEGAN ON (B)(6) 2016 AFTER RECEIVING NO DELIVERY ALARMS. CUSTOMER DID CONTACT THEIR HEALTHCARE PROFESSIONAL. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARED NORMAL. THERE WERE NO LEAKS OR AIR BUBBLES. THERE WERE NO SITE OR INSULIN ISSUES, HOWEVER, IT WAS A PAST EVENT AND CUSTOMER WAS NOT ABLE TO CHECK ISSUES. CUSTOMER DECLINED TO CHECK IF SETTINGS WERE CORRECT. INSULIN PUMP PASSED SELF-TEST. CUSTOMER WAS NOT ABLE TO COMPLETE TROUBLESHOOTING DUE TO GOING TO SEE THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799803 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other