BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3800825 · Received May 8, 2014

    Report

    Report Number
    2032227-2014-02129
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    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 PATIENT CALLED THE PARAMEDICS DUE TO LOW BLOOD GLUCOSE LEVELS. IT WAS STATED THAT THE PATIENT WAS NOT HAVING PROBLEMS WITH THE INSULIN PUMP AT THE TIME, AND HAS NOT HAD ANY ISSUES SINCE THE EVENT. ATTEMPTED TO CONTACT THE PATIENT FOR MORE INFORMATION, BUT GOT THE PATIENT'S VOICEMAIL EACH TIME. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279013 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention