BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103473 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26396
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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

    INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. INSULIN PUMP WAS UNABLE TO PERFORM THE DISPLACEMENT TEST AND VERIFY CHECK SETTINGS, MOTOR ERROR ALARM DUE TO NO BUTTON RESPONSE. MOTOR PASSED MOTOR TEST. INSULIN PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED SEVERAL ALERTS, INCLUDING MOTOR ERROR ALARMS ON THE INSULIN PUMP, WHILE SHE WAS UPDATING HER BLOOD GLUCOSE. THE CUSTOMER ALSO REPORTED ONE OF THE BUTTONS WAS VERY HARD TO PUSH. THE CUSTOMER'S BLOOD GLUCOSE WAS 180 MG/DL. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE INSULIN PUMP DID GO THROUGH A FULL BODY SCANNER AT ONE POINT. THE CUSTOMER USES THE SENSOR FEATURE ON THE INSULIN PUMP. SHE WAS ADVISED THAT A FALSE MOTOR ERROR ALARM COULD BE CAUSED BY VIEWING THE SENSOR GLUCOSE GRAPH WHILE THE INSULIN PUMP DELIVERS A BOLUS. THE CUSTOMER WAS ABLE TO REWIND THE INSULIN PUMP AND WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584146 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR