BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3903430 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86193
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 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

    INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION TEST, PRIME/A33 AND DISPLACEMENT TEST. STUCK IN MOTOR ERROR LOOP DURING BOLUS/BASAL DELIVERY. UNABLE TO CONFIRM E70 ERROR ALARM DUE TO ERASED HISTORY FILE. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUT TESTING. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. UNABLE TO VERFIY A35 ALARMS OR PERFORM A21 ERROR TEST DUE TO MOTOR ERROR ALARMS. NO UNEXPECTED LOOSING OF SETTING ANOMALY NOTED. CRACKED CASE AT DISPLAY WINDOW CORNERS AND MINOR SCRATCHED 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

    IT WAS REPORTED THAT THE INSULIN PUMP IS ALARMING AND RESETTING. ALL SETTINGS ARE ERASED. THIS IS THE FOURTH TIME THIS HAS HAPPENED. DURING TROUBLESHOOTING, THE DISPLACEMENT TEST FAILED. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379895 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 36 YR