BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3123049 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-93884
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. 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 EXPERIENCED HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING IS 355 MG/DL. CUSTOMER HAS TREATED WITH BOLUS. CUSTOMER STATED THAT THERE WAS A HOSPITALIZATION DUE TO DIABETIC KETOACIDOSIS. CUSTOMER'S BLOOD GLUCOSE READING AT TIME OF EVENT WAS 355 MG/DL. CUSTOMER WAS TREATED AND RELEASED. DURING TROUBLESHOOTING, TIME AND DATE ARE CORRECT. PROGRAMMING CORRECT. MANUAL PRIME CORRECT, INSULIN DID EXIT THE TUBING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224732 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization