BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141960 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-32930
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE BUTTONS ON THE INSULIN PUMP'S KEYPAD WERE UNRESPONSIVE DURING A BOLUS ATTEMPT. CUSTOMER REPORTED THAT THE NUMBERS ON THE DISPLAY SCREEN WERE RAMPING. BLOOD GLUCOSE LEVEL WAS 128 MG/DL AT THE TIME OF THE CALL. CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THE ERROR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621634 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH A3523NAHJ

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR