BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3123043 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-93824
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    CUSTOMER'S FATHER CALLED TO REPORT A HOSPITALIZATION DUE TO DIABETIC KETOACIDOSIS. CALLER STATED THAT CUSTOMER WAS RUNNING HIGH BLOOD GLUCOSE AT SCHOOL. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 429 MG/DL. CUSTOMER TREATED WITH IV. DURING TROUBLESHOOTING, THE INSULIN PUMP'S TIME AND DATE OFF ONE HOUR DUE TO DAYLIGHT SAVINGS. PROGRAMMING IS CORRECT. MANUAL PRIME IS CORRECT, INSULIN EXITS THE TUBING. HIGH PRESSURE TEST PASSED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224730 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization