BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974279 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05297
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 28, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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

    THE CUSTOMER REPORTED HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE LEVEL WAS 351 MG/DL. THE PATIENT ALSO STATED THAT THE INSULIN PUMP MAY NOT BE DELIVERING INSULIN PROPERLY. DURING TROUBLESHOOTING, THE INSULIN PUMP PASSED A DRIVE SUPPORT CAP TEST AND A MANUAL PRIME TEST BUT THE DEVICE ALARMED LOW BATTERY AFTER A BATTERY INSTALLATION. THE PROPER METHODOLOGY FOR INSERTION WAS EXPLAINED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450145 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR