BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141114 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-18978
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS CHANGING THE BATTERY OF THE INSULIN PUMP AND THEY TRIED SEVEN DIFFERENT BATTERIES, AND THE DEVICE ALERTED BATTERY OUT LIMIT. THE CUSTOMER'S BLOOD GLUCOSE WAS 159 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD ALSO ALARMED FAILED BATTERY TEST. THE CUSTOMER STATED THAT THEY WERE USING A BATTERY THAT HAD BEEN USED BEFORE AND THEY STATED THAT THEY WERE NOT USING ENERGIZER BATTERIES. TROUBLESHOOTING WAS NOT PERFORMED BECAUSE THE CUSTOMER DID NOT HAVE NEW BATTERIES. THEY STATED THAT THEY WOULD CALL BACK IF THE ISSUE CONTINUES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618198 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR