BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722CAS PRDGM INS V2.2 SK EN PR

    MDR report key: 2821301 · Received October 21, 2010

    Report

    Report Number
    3004209178-2010-83160
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 18, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    CGA
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 HIGH BLOOD GLUCOSE AND WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. IT WAS STATED THAT THE CUSTOMER'S GLUCOSE LEVEL WAS IN THE HIGH 30'S MMOL/L ALL WEEK. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722CAS PRDGM INS V2.2 SK EN PR INFUSION PUMP CGA MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722CAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization