BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4112162 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27562
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    A CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON THE DISPLAY WINDOW WERE NOTED DURING THE VISUAL INSPECTION. ALL OF THE BUTTONS FUNCTIONED PROPERLY. HOWEVER, CORRODED KEYPAD TRACES WERE NOTED. NO BUTTON ERROR ALARM WAS NOTED. NO NUMBER RAMPING ANOMALY WAS NOTED ON THE DISPLAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND WAS NOT GIVING INSULIN FOR A FEW HOURS. THIS CAUSED THE CUSTOMER'S BLOOD GLUCOSE READINGS TO GO UP 400 MG/DL TO 500 MG/DL AND WAS TREATED WITH A MANUAL INJECTION. IT WAS ALSO REPORTED THAT THE CUSTOMER ATTEMPTED TO BOLUS AND THE NUMBERS WERE RAMPING. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592347 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR