BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REALT-IME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143387 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29762
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH INTERMITTENT UP BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACE. NO STICKY BUTTONS NOTED DURING TESTING. INSULIN PUMP FUNCTIONED PROPERLY DURING REWIND AND BASIC OCCLUSION, OCCLUSION, PRIME, THE EXCESSIVE NO DELIVERY AND DISPLACEMENT TEST. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR SEVERAL DAYS. THE CUSTOMER'S BLOOD GLUCOSE HAD BEEN ABOVE 600 MG/DL. THE CUSTOMER HAD GONE TO THEIR DOCTOR. THE CALLER ALSO STATED THAT THE INSULIN PUMP HAD UNRESPONSIVE AND STICKING BUTTONS. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. THE CALLER DECLINED TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE SINCE THE INSULIN PUMP WAS BEING REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603313 PARADIGM REALT-IME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR