BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2990685 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-91604
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 OF 252MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER MENTIONED THAT THE INSULIN PUMP ALARMED NO DELIVERY AND HAS BEEN STRUGGLING WITH HIGH BLOOD GLUCOSE FOR A MONTH. THE TIME, DATE, AND BOLUS WIZARD SETTINGS WERE CORRECT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS RECESSED. ASSISTED THE CALLER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. PERFORMED A HIGH PRESSURE TEST AND PASSED. THE CUSTOMER STATED THAT THE CANNULA WAS NOT BENT OR OCCLUDED. THE DISPLACEMENT AND SELF TEST WAS PERFORMED AND THEY PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94344 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization UNOMEDICAL INFUSION SET