BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3854951 · Received June 9, 2014

    Report

    Report Number
    2032227-2014-02951
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH
    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. 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. BOLUS DELIVERED PROPERLY DURING TESTING AND NO BOLUS ANOMALY NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE OF 700 MG/DL. THE CUSTOMER STATED THAT HIS KNEES WERE CRAMPING AND HE WAS ON THE VERGE OF DIABETIC KETOACIDOSIS. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE EMERGENCY ROOM VISIT. THE CUSTOMER WAS TREATED WITH MANUAL INJECTIONS AND THE BLOOD GLUCOSE READING WAS 224 MG/DL AT THE TIME OF DISCHARGE. THE CUSTOMER STATED THAT THE INSULIN PUMP IS NOT DELIVERING INSULIN. THE CUSTOMER WENT TO SEE HIS DOCTOR FOR SYMPTOMS OF DIABETIC KETOACIDOSIS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336170 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization