BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123395 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29676
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 PASSED THE BASIC OCCLUSION TEST AND THE DISPLACEMENT TEST. NO MOTOR ERROR ALARM WAS NOTED. HOWEVER, THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR RESISTOR. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE OF 500 MG/DL. THEY STATED THAT EVERY 8 WEEKS THEY GET HIGH BLOOD GLUCOSE AND THEY USE MANUAL INJECTIONS TO TREAT. THEY STATED THAT THE DEVICE RECORDS AS INSULIN BEING DELIVERED BUT THEIR BLOOD GLUCOSE REMAINS UNCHANGED. THE CUSTOMER STATED THAT IT MIGHT BE THEIR FAULT BECAUSE THEY WERE ON SOME QUESTS AND CONSUMED A LOT OF CARBOHYDRATES. AT BEDTIME THEIR BLOOD GLUCOSE WAS 67 MG/DL. THEY ATE SOME PEANUT BUTTER. LATER THEIR BLOOD GLUCOSE INCREASED TO 133 MG/DL, 292 MG/DL, AND AT THE TIME OF THE CALL IT WAS 298 MG/DL. TROUBLESHOOTING WAS PERFORMED AND EVERYTHING TESTED WITHIN SPECIFICATION. THE DRIVE SUPPORT CAP OF THE INSULIN PUMP WAS RECESSED. IN THE ALARM HISTORY THERE WERE LOW RESERVOIR AND LOW BATTERY ALERTS PRESENT. LATER, THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER DOES NOT USE THE SENSOR FEATURE. THEY WERE ABLE TO COMPLETE THE REWIND SEQUENCE. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600065 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR