BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3000651 · Received March 12, 2013

    Report

    Report Number
    3004209178-2013-91801
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 2, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN PROPERLY. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS 88MG/DL FOR BREAKFAST, THEN IT WENT OVER 200MG/D FOR LUNCH, AND LAST HER GLUCOSE LEVEL WAS 350MG/DL AT TIME OF CALL. THE CUSTOMER STATED THAT WHEN THE INSULIN PUMP GETS TO ONE THIRD OF THE RESERVOIR, THE DEVICE DOES NOT DELIVER THE FULL AMOUNT OF INSULIN NEEDED. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE ALARM HISTORY AND FOUND A LOW RESERVOIR ALARM. ASSISTED THE CALLER TO PROGRAM A BOLUS AND THE BOLUS HISTORY RECORDED THE BOLUS. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103043 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR