BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4862744 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-67895
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 4, 2015
    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. 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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED INTERMITTENT BUTTON RESPONSE DUE TO FLATTENED UP BUTTON DOME SWITCH. NO BUTTON ERROR ALARM. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND BROKEN BELT CLIP SLOT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE, THE UP ARROW BUTTON ON THE INSULIN PUMP GOT STUCK. THEN THE DEVICE ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 197 MG/DL. THE DEVICE WAS NOT EXPOSED TO MOISTURE OR DROPPED NOR FALLEN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE, REVERT TO BACK UP PLAN, AND THE DEVICE NEED TO BE REPLACED. HE AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405036 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR