BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3981917 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-05629
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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 DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND EXCESSIVE NO DELIVERY TESTS. NO MOTOR ERROR ALARM NOTED, THE MOTOR PASSED MOTOR TEST. NO EXCESSIVE NO DELIVERY ALARMS NOTED. THE TEST MINI LINK TRANSMITTER COMMUNICATES PROPERLY TO THE INSULIN PUMP. NO DO NOT INSTALL PROPERLY ALARM NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP KEPT ALARMING RESERVOIR NOT INSTALLED PROPERLY, NO DELIVERY, AND HAS ALARMED MOTOR ERROR TWICE. HE USUALLY REINSERTS THE RESERVOIR AND IT CORRECTS THE ISSUE. ALARMS CONFIRMED ON THE DEVICE. CUSTOMER BLOOD GLUCOSE LEVEL WAS 199 MG/DL. UNABLE TO PERFORM TROUBLESHOOTING FOR NO DELIVERY SINCE IT WAS A PAST EVENT. MOTOR ERROR ALARM OCCURRED DURING BASAL. CUSTOMER DOES NOT RECALL ANY SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE DEVICE TO ALARM. THE DEVICE WAS NOT EXPOSED TO MRI. ALARM WAS CLEARED. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE. CUSTOMER DOES USE THE SENSOR FEATURE. CUSTOMER WAS ADVISED ABOUT FALSE MOTOR ERROR ALARMS OCCURRING, IF CUSTOMER TRIED TO SEE THE SENSOR GLUCOSE GRAPH WHILE BOLUSING. CUSTOMER WAS ABLE TO REWIND THE DEVICE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER INQUIRED WHAT WAS ISIG. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457947 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR