BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3873296 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85720
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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. UNIT WAS RECEIVED WITH CRACKED WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN TO REPORT THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL IS 500 MG/DL. THE CUSTOMER REPORTED THAT HER DEVICE WAS EXPERIENCING SOME ISSUES. HER DEVICE WAS RECEIVING FREQUENT MOTOR ERRORS AND INTERMITTENT NO DELIVERY ALARMS. SHE STATED THAT THE LOOSE MOTOR SUPPORT DISK WAS PROTRUDED OR STICKING OUT. WE ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE DEVICE AND TO RETREAT TO A BACK UP PLAN. TROUBLESHOOTING WAS PERFORMED ON THE DEVICE AND IT WAS FOUND THAT THE CALLER'S BASAL RATES AND BOLUS WIZARD SETTINGS WERE CORRECT. THE CALLER STATED THAT THE NO DELIVERY ALARM WAS RESOLVED BY A COMPLETE INFUSION SET CHANGE. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349071 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization