BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-551NAP

    MDR report key: 4212478 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43297
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD THE PROBLEM WITH SENSOR ON INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 25 MG/DL. THE CUSTOMER'S WAS ABLE TO TREAT WITH FOOD. THE PATIENT'S STATED THAT HER SUGAR GLUCOSE WAS LOW AND GO TO THRESHOLD SUSPEND AND HER BLOOD GLUCOSE LEVEL WILL GO UP 100 MG/DL. THE CUSTOMER'S WAS ADVISED TO CHANGE SENSOR. THE THRESHOLD SUSPEND WAS RESOLVED. THE CUSTOMER DOES NOT EXHIBIT LOW SYMPTOMS OF BLOOD GLUCOSE LEVEL. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680884 530G INSULIN PUMP MMT-551NAP OZO MEDTRONIC MINIMED MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening