BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4243973 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50374
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    August 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION AND HAD OPERATING CURRENTS WITHIN SPECIFICATION. NO UNEXPECTED ERROR ALARMS WERE NOTED. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD TO SET UP THE TIME AND DATE EVERY TIME ON HER NEW INSULIN PUMP. CUSTOMER HAS HAD AN EXTERNAL RAM ERROR ALARM AND AN UNEXPECTED RESTART ALARM. CUSTOMER STATED THAT THE ALARMS OCCURRED WHEN SHE CHANGED OUT THE BATTERIES. CUSTOMER EXPERIENCED AN UNEXPECTED RESTART. CUSTOMER WAS ADVISED TO MONITOR THE PUMP AND CALL BACK IF ISSUES RECUR. CUSTOMER DID NOT WANT TO TROUBLESHOOT FOR THE ALARM. CUSTOMER WAS TOLD THAT THIS USUALLY HAPPENS WHEN THE PUMP HAS AN UNEXPECTED RESTART. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726163 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR