BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 3972333 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05137
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 EXPERIENCED BLOOD AT THE INSERTION SITE OF THE INFUSION SET. THE BLOOD GLUCOSE READING WAS 44 MG/DL. CUSTOMER TREATED THE LOW BLOOD GLUCOSE BY EATING. THE SITE DID NOT SHOW ANY SIGNS OF INFECTION. CUSTOMER IS USING PROPER INSERTION TECHNIQUES. THERE WAS STILL BLOOD AT THE SITE AT THE TIME OF THE REPORT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447853 MODEL NOT SPECIFIED INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR