BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3884516 · Received June 19, 2014

    Report

    Report Number
    2032227-2014-03124
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BG OF 457 MG/DL. IT WAS STATED THAT THE PATIENT WAS NOT FEELING WELL, AND BEGAN VOMITING. THE MOTHER STATED THAT THE PUMP GAVE A MOTOR ERROR ALARM PRIOR TO THE HOSPITALIZATION, AND THE DOCTOR WANTED THE PUMP REPLACED. THE MOTHER DECLINED TO TROUBLESHOOT AS THE DOCTOR FELT IT WAS NOT WORKING PROPERLY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361370 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization