BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2931828 · Received January 28, 2013

    Report

    Report Number
    2032227-2013-00378
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    THE CALLER STATED THAT HE IS AN HCP, AND HAS A COUSIN WHOSE CHILD WEARS THE SENSOR. THE CALLER STATED THAT THE SENSOR CANNULA BROKE OFF, AND REMAINED UNDERNEATH THE CUSTOMER'S SKIN. THE CALLER DID NOT PROVIDE THE CUSTOMER'S INFORMATION, AND JUST WANTED TO KNOW WHAT THE CUSTOMER SHOULD DO. ADVISED THE CALLER TO HAVE THE CUSTOMER SEEK MEDICAL ATTENTION, AND THEN CALL US TO REPORT THE EVENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37905 MODEL NOT SPECIFIED INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1