BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4123362 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29697
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 436 MG/DL, WHICH WAS TREATED WITH MANUAL INJECTIONS UPON ADMITTANCE. THE CUSTOMER'S MOTHER STATED THAT THE INSULIN PUMP HAD ALARMED NO DELIVERY PRIOR TO THE HOSPITALIZATION. SHE DECLINED GIVING FURTHER DETAILS REGARDING THE HOSPITALIZATION. UPON TROUBLESHOOTING, INSULIN DID EXIT DURING A FIXED PRIME. THE INFUSION SET COULD NOT BE REMOVED AT THE TIME OF THE CALL TO EXAMINE THE CANNULA. ADVISED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET. SHE STATED THAT THE CUSTOMER WOULD CHANGE THE SET AS SOON AS POSSIBLE AND DID NOT REQUIRE ANY FURTHER ASSISTANCE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602874 INSULIN INFUSION PUMP CGM MDS MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization