BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAB PRDGM INSULIN BLUE EN

    MDR report key: 1921839 · Received December 6, 2010

    Report

    Report Number
    3004209178-2010-83514
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 ADMITTED IN THE INTENSIVE CARE UNIT FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 292 MG/DL. TROUBLESHOOTING WAS NOT PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization