BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5248997 · Received November 25, 2015

    Report

    Report Number
    2032227-2015-69177
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    November 8, 2015
    Report Date
    November 9, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 VIA PHONE CALL INDICATING THAT THE INSULIN PUMP ALARM REPROGRAM. CUSTOMER'S BLOOD GLUCOSE WAS 178 MG/DL. THE CUSTOMER WAS ASSISTED WITH PROGRAMING TIME/DATE. THE CUSTOMER WAS UNABLE TO PROGRAM A NORMAL OR EASY BOLUS INTO AIR SINCE PUMP WILL NOT TURN ON DUE TO LOST BATTERY CAP. THE CUSTOMER WAS ADVISED TO CALL BACK ONCE SHE RECEIVE THE NEW BATTERY CAP IN ORDER TO TROUBLESHOOT. THE CUSTOMER WAS ADVISED THAT WE WILL SEND A NEW BATTERY CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781144 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR