BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3943054 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87697
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    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 PASSED THE REWIND, BASIC OCCLUSION TEST, PRIME TEST AND DISPLACEMENT TEST. INSULIN PUMP RECEIVED STUCK IN THE MOTOR ERROR LOOP DURING BOLUS AND BASAL DELIVERY. UNABLE TO CONFIRMED MOTOR POSITION ENCODER ERROR ALARM DUE TO ERASED HISTORY FILE. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. UNABLE TO VERIFY MOTION SENSOR TEST FAILURE ALARMS DUE TO MOTOR ERROR ALARMS. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND BATTERY TUBE THREADS AND MINOR SCRATCHES ON DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A MOTOR ERROR ALARM ON HIS INSULIN PUMP. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED AS THE CUSTOMER WAS SHORT ON TIME AND THE INSULIN PUMP WAS NOT ALLOWING HIM TO FURTHER TROUBLESHOOT. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418030 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 40 YR