BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4152793 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-20033
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    THE CUSTOMER WAS HAVING ISSUES WITH THE INSULIN PUMP. THEIR BLOOD GLUCOSE WAS 167 MG/DL, WHICH WAS CONSIDERED LOW FOR THE CUSTOMER. THE CALLER WANTED TO KNOW WHAT WOULD BE THE NEXT STEP. THEY WERE ADVISED TO DELIVER INSULIN. THE CUSTOMER HAD ALREADY DELIVERED 10.3 UNITS OF INSULIN AND THEIR BLOOD GLUCOSE WAS DECREASING; IT HAD GONE TO 144 MG/DL. THE CALLER STATED THAT IF THE CUSTOMER'S BLOOD GLUCOSE DROPS BELOW 140 MG/DL, THEN IT WILL START DROPPING RAPIDLY. THE CALLER WAS ADVISED THAT IT COULD BE TREATED WITH FOOD OR DRINK. THE INSULIN PUMP TARGET LEVEL WAS SET UP TO 110MG/DL-120 MG/DL. THE CALLER STATED THIS COULD TAKE THE CUSTOMER TO THE HOSPITAL. THE CUSTOMER DISCONNECTED FROM THE INSULIN PUMP BECAUSE THEY THOUGH THE DEVICE WAS GIVING 10 UNITS OF INSULIN. THE BOLUS HISTORY SHOWED BLOOD GLUCOSE 247 MG/DL, 10 UNITS OF ACTIVE INSULIN, BLOOD GLUCOSE 275 MG/DL, 3.8 UNITS, BLOOD GLUCOSE 353 MG/DL, 8.0 UNITS. THE CUSTOMER WAS HARD OF SEEING THE SCREEN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630581 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR