BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAP PRDGM INS V2.2 PL EN

    MDR report key: 1180067 · Received September 26, 2008

    Report

    Report Number
    3004209178-2008-00782
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    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 A WEEK DUE TO DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS OVER 300 MG/DL. THE CUSTOMER STATED THAT SHE BEGAN VOMITING AND ENDED UP IN THE HOSPITAL FOR HIGH BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAP PRDGM INS V2.2 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization