BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103505 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26465
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    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 REWIND, BASIC OCCLUSION, PRIME AND DISPLACEMENT TESTS. PUMP RECEIVED WITH STUCK MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. UNABLE TO VERIFY E70 ALARM IN THE ALARM HISTORY DUE TO HISTORY FILE OVERWRITTEN. PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, BROKEN RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS 483 MG/DL, WHICH WAS TREATED WITH EIGHT UNITS OF MANUAL INJECTION. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS DROPPED. THE CUSTOMER DOES NOT USE THE SENSOR FEATURE. THEY WERE UNABLE TO REWIND THE DEVICE. THE CUSTOMER ALSO STATED THAT PRIOR TO THE MOTOR ERROR ALARM THERE WERE SEVERAL NO DELIVERY ALARMS. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583695 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention