BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2912246 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-90249
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 28, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    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 BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OVER 600MG/DL. THE CUSTOMER STATED THAT WHILE CHANGING THE INSULIN VILE FOUND INSULIN DENTURE. TROUBLESHOOTING WAS PERFORMED. ASSISTED THE CUSTOMER TO RUN THE HIGH PRESSURE TEST AND PASSED. INSTRUCTED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. THE TIME, DATE, AND BOLUS WIZARD WERE CORRECT. THE CUSTOMER RAN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. THE CALLER MENTIONED THAT HE HAD PAIN ON HIS TEETH, WHICH MAY HAVE CAUSED HIS GLUCOSE LEVEL TO RISE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17372 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization