BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3990234 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-91191
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER CALLED BECAUSE HER DAUGHTER'S INSULIN PUMP HAS AN OPEN CIRCLE ON THE SCREEN AND SHE CANNOT CLEAR IT. THROUGH TROUBLESHOOTING, IT WAS DISCOVERED THAT THE INSULIN PUMP WAS SET TO PATTERN A, RATHER THAN NORMAL BASAL RATES. THE DEVICE WAS RESET WITH THE PROPER SETTINGS. CUSTOMER'S BLOOD GLUCOSE WAS 39 MG/DL. IT WAS LOW DUE TO THE DEVICE RUNNING PATTERN A INSTEAD OF THE NORMAL BASAL RATES. ALSO, CUSTOMER HAD A BOLUS DELIVERY AND ADDITIONAL INSULIN. CUSTOMER DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS CHECKED AT THE END OF THE CALL AND IT WAS 249 MG/DL. CUSTOMER WAS SICK, SO THIS WAS THE REASON FOR THE HIGH. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463201 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention