BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2984081 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-91452
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 17, 2013
    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 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 EXPERIENCED LOW BLOOD GLUCOSE OF 49MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSHED. REVIEWED THE PROGRAMMING ON THE INSULIN PUMP AND IT SEEMS EVERYTHING WAS CORRECT. THE RESERVOIR HAS THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88052 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR