BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3013858 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-92001
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 432MG/DL. IT WAS STATED THAT THE CUSTOMER EXPERIENCED DRY MOUTH AND DIZZINESS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER MENTIONED THAT SOMETIMES THE INSULIN PUMP DOES NOT GIVE HIM THE INSULIN HE NEEDS WHEN HE HAS HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE WAS 230MG/DL. HE PROGRAMMED 0 CARBOHYDRATES AS HE WAS NOT EATING AND ONLY GOT 1.5 UNITS WHEN HE SHOULD HAVE RECEIVED 4 OR 5 UNITS. ASSISTED THE CALLER TO REVIEW THE BOLUS HISTORY AND SHOWS THAT IN SOME HOW HE HAD ACTIVE INSULIN AT THE TIME, WHICH IS WHY HE GOT 1.5 UNITS INSTEAD OF 4.6 UNITS. THE CALLER STATED THAT THE CUSTOMER HAD A LOT OF SCAR TISSUE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115638 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization