BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972284 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88678
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FUNCTIONED PROPERLY DURING THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. NO MOTOR ERROR OR EXCESSIVE NO DELIVERY ALARMS WERE NOTED. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED THE MOTOR TEST. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE NEAR THE RESERVOIR TUBE WINDOW AND CRACKED BATTERY TUBE THREADS.

    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 BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING NO DELIVERY AND MOTOR ERROR. CUSTOMER STATES THAT THEY HAVE CHANGE THE RESERVOIR AND INFUSION SET, YET ISSUE HAS CONTINUED. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO PERFORM A FIXED PRIME. CUSTOMER STATES THE INSULIN DID NOT EXIT AND THE DEVICE ALARMED NO DELIVERY. NEXT, CUSTOMER WAS ASKED TO REMOVE RESERVOIR AND PERFORM A MANUAL PRIME. CUSTOMER STATES THE INSULIN DID EXIT AND THE DEVICE DID NOT ALARM NO DELIVERY. ADVISED CUSTOMER THE ISSUE MIGHT BE AN OCCLUDED INSERTION SITE. ADVISED CUSTOMER TO REPLACE RESERVOIR AND SET. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 257 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448243 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR