BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982348 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90255
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD MOISTURE DAMAGE WAS FOUND ON KEYPAD TRACES. ALL BUTTONS FUNCTION PROPERLY AND NO FROZEN SCREEN NOTED. INSULIN PUMP PASSED UNEXPECTED AND SELF TEST. NO ALARMS NOTED. INSULIN PUMP WAS MONITORED FOR 24 HOURS WITH MULTIPLE BASAL RATES. NO ALARMS DURING TESTING. AN ALARM WAS IN PUMP HISTORY DUE TO CORRUPTED HISTORY FILE. INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SCREEN OF THE INSULIN PUMP BECAME FROZEN. THE BLOOD GLUCOSE READING WAS 265 MG/DL. THE INSULIN PUMP GAVE OFF A SAFETY ALARM DUE TO BEING STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME. CUSTOMER ALSO REPORTED THAT THE BUTTONS BECAME UNRESPONSIVE. SHE COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THIS KEYPAD ISSUE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457667 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR