BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4082668 · Received September 11, 2014

    Report

    Report Number
    2032227-2014-21492
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY AFTER A BATTERY REPLACEMENT. THE CUSTOMER'S MOTHER STATED THAT ALL THE SETTINGS WERE GONE FROM THE INSULIN PUMP AND THAT THE CUSTOMER WAS AWAY AT WORK. THE BLOOD GLUCOSE READING WAS UNKNOWN. ADVISED THAT REPLACEMENT OF THE INSULIN PUMP WOULD BE POSSIBLE AFTER THE ISSUES UNDERWENT TROUBLESHOOTING PROCEDURES. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562172 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR