BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945109 · Received July 18, 2014

    Report

    Report Number
    2032227-2014-04572
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. THE INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTONS DUE TO FLATTENED UP ARROW DOME SWITCH. NO BUTTON ERROR ALARMS NOTED. THE INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON LCD WINDOW.

    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 THE INSULIN PUMP WAS ALARMING BUTTON ERROR, AND WAS UNABLE TO CLEAR THE ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 145 MG/DL. CUSTOMER STATED THE DEVICE HAS NOT BEEN EXPOSED TO ANY MOISTURE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421561 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR