BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3801139 · Received May 8, 2014

    Report

    Report Number
    2032227-2014-02321
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 17, 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

    IT WAS REPORTED THAT THE CUSTOMER HAD UNEXPLAINED LOW BLOOD GLUCOSE OF 24 MG/DL BECAUSE HER INSULIN PUMP WAS OVER DELIVERING. CALLER STATED THAT THE CUSTOMER HAD 70 UNITS OF INSULIN ACTIVE IN HER BODY. CALLER STATED THAT SHE WAS TREATING WITH GLUCOSE TABLETS. VERIFIED PROGRAMMING AND FOUND THAT THE BOLUS HISTORY WAS INCORRECT. THE INSULIN PUMP DELIVERED 20 UNITS OF INSULIN WHEN CUSTOMER'S BLOOD GLUCOSE WAS 113 MG/DL. ALSO FOUND THAT 300 CARBOHYDRATES WERE ENTERED INTO THE INSULIN PUMP SEVERAL TIMES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277740 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR