BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4141743 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33503
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    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 HAD TWO FAULTY RESERVOIRS. THE CALLER STATED THAT THE RESERVOIR HAD BEEN CHANGED AND THE BLOOD GLUCOSE READING WAS 19 MG/DL. THE MOST RECENT BLOOD GLUCOSE READING WAS 25 MG/DL. NEITHER THE INSULIN PUMP NOR THE RESERVOIR WERE AVAILABLE FOR TROUBLESHOOTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621170 INSULIN INFUSION PUMP CGM MDS MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1