BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3062044 · Received April 16, 2013

    Report

    Report Number
    2032227-2013-01411
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC MINIMED
    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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. NO BLOOD GLUCOSE READING WAS REPORTED. THE CALLER STATED THAT THE INSULIN PUMP WAS OUT OF WARRANTY, AND SHE WANTED TO MOVE FORWARD WITH THE UPGRADE PROCESS AND THEY DIDN'T KNOW IF HE INSULIN PUMP WAS WORKING PROPERLY. SPOKE WITH THE CUSTOMER'S MOTHER AND EXPLAINED THE UPGRADE PROCESS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161993 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization