BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5170572 · Received October 23, 2015

    Report

    Report Number
    2032227-2015-58772
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    October 3, 2015
    Report Date
    October 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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 CALLED IN TO REPORT A BATTERY OUT LIMIT ALARM AND AN AFTER BATTERY CHANGE ALARM AFTER CHANGING THE BATTERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200 MG/DL. DURING TROUBLESHOOTING, THE CUSTOMER RECEIVED A FAILED BATTERY TEST ALARM. THE CUSTOMER WAS SENT A REPLACEMENT BATTERY CAP AND WAS ADVISED TO REVERT TO A BACK-UP PLAN UNTIL THE CAP ARRIVED. NOTHING WAS REPLACED OR RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700752 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 44 YR