BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3894854 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03347
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP PASSED FUNCTIONAL TESTING INCLUDING DISPLACEMENT, PRIME, NO DELIVERY, REWIND, BASIC OCCLUSION, AND OCCLUSION TESTS. THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. NO PRIME ANOMALIES WERE NOTED. NO DISPLAY RAMPING ANOMALY NOTED. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO REPORT A KEYPAD ANOMALY ON HER INSULIN PUMP. THE BLOOD GLUCOSE READING AT THE TIME OF CALL WAS 125 MG/DL. CUSTOMER HAD CHANGED THE INFUSION SET AND WAS IN THE PRIMING PROCESS WHEN SHE RECEIVED AN ALERT ABOUT BOLUS DELIVERY. AT THIS POINT THE BUTTONS ON THE INSULIN PUMP STOPPED RESPONDING. REPLACEMENT PUMP SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370495 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR