BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4002457 · Received August 12, 2014

    Report

    Report Number
    2032227-2014-07422
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 13, 2014
    Report Date
    July 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD A BUTTON ERROR ALARM AND NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE, BROKEN RESERVOIR TUBE LIP AND MINOR SCRATCHES ON DISPLAY WINDOW.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER DOES NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THE ALARM. BLOOD GLUCOSE LEVEL WAS 300 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478132 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS A000207835

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR