BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972420 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05196
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER CALLED TO REPORT A BLANK DISPLAY ON CUSTOMER'S INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE IS 212 MG/DL. CUSTOMER WAS CHANGING THE BATTERY, AND THE DEVICE WOULD NOT TURN BACK ON. THE DEVICE WAS NOT DROPPED OR EXPOSED TO MOISTURE. CUSTOMER IS USING DURACELL BATTERIES. THE BATTERY CAP, BATTERY COMPARTMENT, CONTACTS, AND SPRINGS ARE NOT DAMAGED OR CORRODED. THE DISPLAY DID NOT RETURN AFTER TAKING THE BATTERY OUT FOR TEN MINUTES. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446442 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR