BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972183 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05132
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. SEE MEDWATCH REPORT # 3004209178-2014-88703.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD OPERATING CURRENTS WITHIN SPECIFICATION. THE INSULIN PUMP PASSED THE SELF TEST, UNEXPECTED RESTART ERROR TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. THE INSULIN PUMP WAS TESTED WITH A TEST WATER FILL RESERVOIR AND NO AIR BUBBLE ANOMALY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING ISSUES WITH AIR BUBBLES IN THE INSULIN. SHE STATED THAT SHE LEAVES THE INSULIN OUT AT ROOM TEMPERATURE BUT THE BUBBLES ARE STILL THERE. THE SET AND THE RESERVOIRS ARE NOT EXPIRED. CUSTOMER WAS FOLLOWING PROPER PROCEDURES. SHE STATED THAT SHE HAD TO PRIME OUT AIR BUBBLES EVERY DAY AND FEELS THAT THESE AIR BUBBLES ARE THE CAUSE OF HER HIGH BLOOD GLUCOSE. SHE STATED THAT SHE FELT IT WAS A VACUUM ISSUE AND THAT THE PISTON WAS NOT PUSHING IN THE RESERVOIR PROPERLY, CAUSING AIR TO BE SUCKED IN. SHE STATED THAT THIS HAS BEEN OCCURRING WITH EVERY RESERVOIR FOR ABOUT A YEAR. THE BLOOD GLUCOSE READING WAS 300 MG/DL. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL AND RECESSED. SHE RAN A MANUAL PRIME AND STATED THAT INSULIN DID EXIT FROM THE TUBING. ALL OF THE SETTINGS IN THE INSULIN PUMP WERE CORRECT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447524 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR