BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3182735 · Received June 21, 2013

    Report

    Report Number
    2032227-2013-02508
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 26, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    CUSTOMER STATED THAT THE INSULIN PUMP IS UNDERDELIVERING INSULIN. CUSTOMER TESTED THE INSULIN PUMP AND SAW A FEW DROPS, SHE DOES NOT FEEL THE INSULIN PUMP IS DELIVERING PROPERLY. NO ALARMS GIVEN. CUSTOMER BLOOD GLUCOSE READING IS 280 MG/DL. CUSTOMER IS EXPERIENCING SLIGHTLY BLURRED VISION AND LIGHT HEADINESS. TIME AND DATE ARE CORRECT. PROGRAMMING IS CORRECT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283591 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR