BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945740 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04713
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    May 25, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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

    THE CUSTOMER CALLED IN TO REPORT THAT THEY WERE RECEIVING A NO BATTERY ALARM ON THEIR PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 120 MG/DL. THE CUSTOMER STATES THAT THE BATTERY CAP IS NOT LOOSE, CRACKED OR DAMAGED. THE CUSTOMER ALSO STATES THAT THIS IS THE SECOND TIME THAT THEY HAVE RECEIVED THE ALARM. WE ADVISED THE CUSTOMER THAT THE PUMP WILL BE REPLACED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426493 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL A000202977

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR