BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4090393 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23084
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.(B)(4).

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD NO MOISTURE DAMAGE FOUND INSIDE. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER GOT INTO THE SWIMMING POOL, ACCIDENTALLY, WHILE THE INSULIN PUMP WAS STILL ATTACHED TO THEM. THE CUSTOMER HAD BEEN IN THE WATER FOR AN HOUR BEFORE THEY REALIZED THEY HAD THE INSULIN PUMP ATTACHED TO THEM. THE CUSTOMER'S BLOOD GLUCOSE WAS 77 MG/DL. THE CALLER STATED THAT THERE WAS NO WATER UNDER THE SCREEN OR ANYWHERE ELSE. THE DISPLAY WAS STILL WORKING, BUT THE CALLER STATED THAT THERE WAS A LARGE SCRATCH ON THE SCREEN, WHICH WAS CAUSED WHEN THE CUSTOMER TRIED TO MOVE A BIG CHAIR. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568252 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR