BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942789 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04286
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    THE INSULIN PUMP HAS INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON KEYPAD TRACE. THE INSULIN PUMP RECEIVED WITH BLEEDING LCD GLASS, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND STAINED END CAP STICKER.

    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 THAT THE DOWN ARROW BUTTON ON HER INSULIN PUMP IS NOT RESPONDING. CUSTOMER STATED THAT SHE DOES NOT RECALL ANY EVENTS LEADING TO THE KEYPAD ISSUE; SHE HAD THE INSULIN PUMP ON HER POCKET ALL DAY. BLOOD GLUCOSE LEVEL 230 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419592 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR