BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4111078 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-23038
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING ISSUES WITH THE INSULIN PUMP AND WAS EXPERIENCING HIGH BLOOD GLUCOSE OF 338MG/DL. THE CALLER TREATED WITH TWO MANUAL INJECTIONS. THE CUSTOMER STATED THAT THE DEVICE WENT ON REWIND MODE ON ITS OWN. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE TIME, DATE, BOLUS WIZARD SETTINGS AND BASAL SETTINGS WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND NO DELIVERY ALARM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591613 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR