BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAL PRDGM INSULIN CLEAR EN

    MDR report key: 1873710 · Received October 13, 2010

    Report

    Report Number
    3004209178-2010-83081
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 29, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE OF 401MG/DL AT DINNER, AND HE HAD SYMPTOMS OF DIABETES KETOACIDOSIS AND ABDOMINAL PAIN. THE MOTHER STATED THAT THE HEALTH PROFESSIONAL TEAM ASSISTED HIM IN GETTING RID OF THE KETONES; HOWEVER, THE CUSTOMER'S BLOOD GLUCOSE STILL WAS HIGH. IT WAS STATED THAT THE CUSTOMER WAS TREATED WITH A MANUAL INJECTION TO LOWER THE HIGH GLUCOSE LEVEL. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 377MG/DL. ASSISTED THE MOTHER THROUGH PROGRAMMING A BOLUS WITH BOLUS WIZARD. REVIEWED BOLUS HISTORY, AND FOUND THAT THE BOLUS ENTRY WAS REGISTERED. THE BASAL, BOLUS, AND DAILY TOTALS APPEARED TO BE CORRECT. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723NAL PRDGM INSULIN CLEAR EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization