BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4821123 · Received June 5, 2015

    Report

    Report Number
    2032227-2015-17925
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 16, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO UNEXPECTED SCROLLING NUMBERS NOTED. THE INSULIN PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON LCD WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE NUMBERS ON THE SCREEN OF THE INSULIN PUMP STARTED SCROLLING WHEN TRYING TO DELIVER A BOLUS. BLOOD GLUCOSE VALUE WAS 168 MG/DL. IT WAS ADVISED TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO A BACK A PLAN. IT WAS ADVISED THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365768 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR