BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAS PRDGM INS V2.1 SK EN

    MDR report key: 1871249 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-83076
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    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 REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS. TROUBLESHOOTING WAS PERFORMED. PROGRAMMING ON THE INSULIN PUMP APPEARED TO BE CORRECT. THE CUSTOMER STATED THAT SHE TREATED HER BLOOD GLUCOSE WITH MANUAL INJECTIONS. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND THE DEVICE PASSED THE TEST. THE CUSTOMER STATED THAT THE INFUSION SET WAS CHANGED THE DAY BEFORE HER ADMISSION, AND WHEN IT WAS REMOVED, THE CUSTOMER NOTICED THAT PUS CAME OUT. THE CUSTOMER STATED THAT SHE SWITCHED THE SITES EVERY TWO TO THREE DAYS. HOWEVER, THE INFUSION SET WORN WHEN SHE HAD AN INFECTION WAS INSERTED INTO HER BODY FOR FOUR DAYS. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization