BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4791247 · Received May 22, 2015

    Report

    Report Number
    2032227-2015-16612
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 11, 2015
    Report Date
    May 4, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP HAD A FAILED BATTERY TEST. CUSTOMER'S BLOOD GLUCOSE WAS 131 MG/DL. THE CUSTOMER WAS ADVISED TO INSERT NEW AAA ALKALINE BATTERY. CUSTOMER STATED THAT THEY DID NOT RECEIVED FAILED BATTERY TEST. THE CUSTOMER WAS ADVISED TO MONITOR INSULIN PUMP AND CALL IF ISSUES PERSIST. THE TROUBLESHOOTING WAS DONE FOR BLANK DISPLAY, CUSTOMER WAS ADVISED TO INSERT NEW AAA ALKALINE BATTERY. CUSTOMER STATED THAT THE DISPLAY RETURNED. THE CUSTOMER WAS ADVISED TO MONITOR AND WE WOULD SEND A REPLACEMENT BATTERY CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336252 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR