BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4801384 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-59950
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 7, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS. THE CALLER ALSO REPORTED THAT THE INSULIN PUMP ALARMED AUTO OFF FREQUENTLY. SHE WAS ADVISED TO TURN THE AUTO OFF ALARM FEATURE OFF IN ORDER TO PREVENT IT FROM OCCURRING. THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER AND THE INSULIN PUMP WERE NOT PRESENT IN ORDER TO TROUBLESHOOT. SHE WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE PRESENT IN ORDER TO PROCEED WITH THE TROUBLESHOOT PROCESS. SHE STATED THAT SHE WOULD CALL BACK IN ORDER TO DOCUMENT THE HIGH BLOOD GLUCOSE HOSPITALIZATION AND ADDRESS THE MATTER. THE CALLER DID NOT KNOW THE BLOOD GLUCOSE READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347741 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization