BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982326 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06178
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THE CUSTOMER NOTICED THE DEVICE WAS A BIT FOGGY ON THE SCREEN AND MAY HAVE RECEIVED A LITTLE CONDENSATION. CUSTOMER WAS AT THE BEACH WAS INSIDE THE HOUSE WHEN THE CONDENSATION WAS NOTED. CUSTOMER'S BLOOD GLUCOSE WAS 232 MG/DL. CUSTOMER REPORTED THE DEVICE MAY HAVE HAD MOISTURE EXPOSURE, SINCE THE DEVICE WAS INSIDE IN THE COLD AIR THEN CUSTOMER STEPPED OUT SIDE IN THE HEAT OUTSIDE; AS A SIGNIFICANT EVENT THAT MAY HAVE CAUSE THE ALARM. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456595 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR