BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NX PRDGM INS BL EN LN

    MDR report key: 1873712 · Received October 13, 2010

    Report

    Report Number
    3004209178-2010-83082
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE CUSTOMER RECENTLY HAD A HYPOGLYCEMIC EPISODE, AND THE PARAMEDICS WERE CALLED. IT WAS STATED THAT THE EMERGENCY TEAM BLAMED THE INSULIN PUMP FOR THE CUSTOMER'S HYPOGLYCEMIA EPISODE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723NX PRDGM INS BL EN LN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NX

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization