BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920885 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86573
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT HIS INSULIN PUMP IS UNDER DELIVERING INSULIN AND NOT ALARMING. CUSTOMER STATED HE WOULD PROGRAM 18.9U OF INSULIN BUT THE DEVICE WOULD ONLY DELIVER BETWEEN 18 TO 16 UNITS. THE PREVIOUS NIGHT, HE ATTEMPTED TO PROGRAM 11U OF INSULIN AND WATCHED AS THE DEVICE ONLY DELIVERED 5.1UNITS. CUSTOMER STATES DEVICE DOES ALARM BUT IS NOT VISIBLE ON THE DEVICE SCREEN. WHILE REPORTING, THE CUSTOMER AGAIN ATTEMPTED TO PROGRAM 13 UNITS OF INSULIN AND THE DEVICE ONLY DELIVERED 7.7U. ADVISED CUSTOMER THAT WITH THE BOLUS NOT WORKING, THE DEVICE SHOULD BE REPLACED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 142 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398296 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR