BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723RNAP PRDGM INS V2.3 PL EN RC

    MDR report key: 1911784 · Received November 24, 2010

    Report

    Report Number
    2032227-2010-83291
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 10, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    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 DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF OVER 900 MG/DL. THE DOCTOR STATED THAT THE CUSTOMER MAY HAVE AN INFECTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723RNAP PRDGM INS V2.3 PL EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization