BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2972057 · Received February 21, 2013

    Report

    Report Number
    2032227-2013-00689
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 THAT SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE OF 712 MG/DL. THE CUSTOMER STATED THAT SHE FELT LIKE SHE WAS HAVING A HEART ATTACK. THE CUSTOMER ALSO STATED THAT SHE HAD A URINARY TRACT INFECTION THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE CUSTOMER DECLINED TROUBLESHOOTING AS SHE FELT THAT THE INSULIN PUMP WAS FUNCTIONING PROPERLY. THE CUSTOMER STATED THAT HER HCP MADE CHANGES TO THE INSULIN PUMP SETTINGS, AND HER BLOOD GLUCOSE LEVELS WENT BACK TO NORMAL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77468 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization