BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841730 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02690
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 12, 2014
    Report Date
    April 24, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    PATIENT

    Narratives

    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. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATIONS AND NO OFF NO POWER OR FAILED BATTERY TEST ALARMS NOTED.

    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

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY FAILURE ANALYSIS THAT WAS NOT INCLUDED ON THE INITIAL DEVICE EVALUATION: THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO REPORT INSULIN PUMP LEAKING INSULIN AND ISSUES WITH SCREEN NOT DISPLAYING NUMBERS. CUSTOMER WAS IN THE HOSPITAL FOR A UNRELATED KIDNEY TRANSPLANT WHEN ISSUES AROSE. CUSTOMER HAD EXPERIENCED LOWS DURING HOSPITALIZATION AT LEAST 4 EVENTS. HOSPITAL IS TREATING HIM WITH IV DRIP. DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT THE DEVICE HAD BEEN WORN WHILE THE PATIENT WAS BEING X-RAYED. THE BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 184 MG/DL. ADVISED CUSTOMER THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318830 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization