BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3642484 · Received February 24, 2014

    Report

    Report Number
    2032227-2014-00885
    Event Type
    Injury
    Date Received
    February 24, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 7, 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 CUSTOMER WAS INITIALLY HOSPITALIZED FOR A BLOOD TRANSFUSION. CALLER STATED THAT THE CUSTOMER'S INSULIN PUMP WAS DISCONNECTED DURING TRANSFUSION. CALLER STATED THAT THE CUSTOMER RECONNECTED WITHOUT CLEANING OR SANITIZING AND SHE ENDED UP GETTING AN INFECTION. CALLER STATED THAT THE CUSTOMER HAD AN ABSCESS REMOVED DUE TO INFECTION ON THE SIDE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113081 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization