BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5355635 · Received January 8, 2016

    Report

    Report Number
    3004209178-2016-80740
    Event Type
    Injury
    Date Received
    January 8, 2016
    Date of Event
    December 21, 2015
    Report Date
    December 24, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    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 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

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 54 MG/DL. THE CUSTOMER STATED THAT PAST ISSUE AND HAD NOT TREATED. THE CUSTOMER WAS EXPERIENCING LOW BLOOD GLUCOSE FOR (B)(6) 2015 47 MG/DL. THE CUSTOMER WAS UNABLE TO COMPLETE THE TROUBLESHOOTING. THE CUSTOMER STATED THAT SHE HAS BEEN GETTING LOST SENSOR. THE CUSTOMER WAS ADVISED TO REMOVED THE TRANSMITTER SO WE COULD CHECK ID ON TRANSMITTER AND THAT IS WHEN SHE HAD TO GET OFF THE PHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11881 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization