BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3090821 · Received May 2, 2013

    Report

    Report Number
    2032227-2013-01588
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 6, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    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. THE INSULIN PUMP HAD A CRACKED CASE AT THE LCD WINDOW CORNERS AND A BLEEDING GLASS. NO DAMAGE TO THE DRIVE SUPPORT CAP WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS BETWEEN 170-280 MG/DL. THE CALLER STATED THAT THE CUSTOMER HAD A VIRAL INFECTION, AND WAS VOMITING. THE CUSTOMER HAD BEEN GETTING NO DELIVERY ALARMS PRIOR TO THE HOSPITALIZATION, AND HAD CALLED IN TO REPORT THE ISSUES PREVIOUSLY. THE CUSTOMER TRIED ALL REMEDIES, BUT CONTINUED TO GET NO DELIVERY ALARMS. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191609 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization