BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAB PRDGM INS V2.2 BL EN

    MDR report key: 1853351 · Received October 1, 2010

    Report

    Report Number
    3004209178-2010-82956
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 5, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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 WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS. THE MOTHER STATED THAT THE MOST RECENTLY CHANGE OF THE INFUSION SET WAS THREE DAYS PRIOR TO THE EVENT. ADVISED THE MOTHER TO CHANGE THE INFUSION SET EVERY TWO TO THREE DAYS. TROUBLESHOOTING WAS PERFORMED. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization