BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4120131 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-18671
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 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

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    ALL OF THE BUTTONS FUNCTIONED PROPERLY. HOWEVER, MOISTURE DAMAGE WAS FOUND ON THE KEYPAD TRACES. NO UNEXPECTED BLANK CIRCLE OR BUTTON ERROR ALARM WAS NOTED DURING TESTING. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER RECEIVED AN ERROR ALARM ON THEIR INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 92 MG/DL. THE CUSTOMER STATED THAT THERE WERE NO SIGNIFICANT EVENTS THAT COULD HAVE LED TO THE ISSUE. THE CALLER WAS THE PATIENT'S MOTHER. THE CUSTOMER WAS INFORMED THAT THE PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. A NEW PUMP WAS SHIPPED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597646 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR