BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3243655 · Received July 23, 2013

    Report

    Report Number
    2032227-2013-03097
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    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 CUSTOMER STATED THAT HE RECEIVED THE SAFETY NOTIFICATION LETTER, AND FEELS HE'S BEEN AFFECTED BY THIS ISSUE FOR A LONG TIME. THE CUSTOMER STATED THAT HE HAS HAD PROBLEMS WITH OVER DELIVERY OF INSULIN, LOW BLOOD GLUCOSE, HIGH BLOOD GLUCOSE AND SEIZURES. THE CUSTOMER WANTED TO SPEAK DIRECTLY WITH THE FDA TO REPORT THE ISSUES. ADVISED THE CUSTOMER THAT HE CAN REPORT THE ISSUES DIRECTLY TO THEM IF HE'D LIKE. GAVE THE CUSTOMER THE FDA PHONE NUMBER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343351 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR