BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4033278 · Received August 25, 2014

    Report

    Report Number
    3004209178-2014-97038
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 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

    FAILURE ANALYSIS REVEALED THAT THE BUTTONS WERE RESPONDING PROPERLY. HOWEVER, MOISTURE DAMAGE WAS FOUND ON THE KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED DURING TESTING. THE DEVICE HAD CRACKED CASE ON THE LCD DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON THE LCD DISPLAY WINDOW, CRACKS ON THE RESERVOIR TUBE LIP, AND BROKEN BELT CLIP SLOT.

    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 A BUTTON ERROR ON HER INSULIN PUMP DURING THE NIGHT. CUSTOMER'S BLOOD GLUCOSE IS 282 MG/DL. THERE WERE NO SIGNIFICANT EVENTS LEADING TO THE ALARM. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512136 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 62 YR