BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4133280 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31485
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    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

    INSULIN PUMP RECEIVED WITH CORRODED KEYPAD TRACES. NO DISPLAY RAMPING ON ITS OWN ANOMALY NOTED. ALL BUTTONS WORKING PROPERLY. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE NUMBERS ON THE SCREEN OF THE INSULIN PUMP KEEP RAMPING AND THE KEYPAD IS UNRESPONSIVE. CUSTOMER DOES NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ISSUE. BLOOD GLUCOSE VALUE IS 185 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610832 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAP A000290378

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR