BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1890142 · Received October 29, 2010

    Report

    Report Number
    3004209178-2010-83243
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    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 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 WAS TAKEN BY AMBULANCE TO THE EMERGENCY ROOM FOR LOW BLOOD GLUCOSE. THE FATHER STATED THAT THE BOLUS HISTORY SHOWED A BOLUS, WHICH WAS PROGRAMMED AND DELIVERED WHILE THE CUSTOMER WAS SLEEPING. THE FATHER BELIEVES THAT THIS WAS THE RESULT OF TOSSING AND TURNING DURING THE CUSTOMER'S SLEEP. THE FATHER MENTIONED THAT THE FRONT PANEL ON THE INSULIN PUMP WAS PEELING OFF. NO FURTHER INFORMATION 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 MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722CAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization