BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3941789 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87508
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A LOW BLOOD GLUCOSE EVENT AND HAD A HARD TIME STABILIZING HER BLOOD GLUCOSE LEVELS. THE MOST RECENT BLOOD GLUCOSE READING WAS 97 MG/DL. THE CUSTOMER CALLED FOR ASSISTANCE WITH PROGRAMMING THE INSULIN PUMP. SHE COMPLAINED THAT SHE FELT LIKE HER BLOOD GLUCOSE WAS LOW SO SHE TREATED WITH APPLE JUICE, BUT SHE DECLINED TROUBLESHOOTING FOR THE MATTER. SHE ALSO NOTED THAT SHE HAD NOT HAD ANYTHING TO EAT YET THAT DAY. THE CUSTOMER REQUESTED ADDITIONAL MATERIALS TO BE SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419027 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR