BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1890151 · Received October 29, 2010

    Report

    Report Number
    3004209178-2010-83238
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 19, 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 HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 500MG/DL. IT WAS STATED THAT THE CUSTOMER WAS TREATED WITH INSULIN DRIP. THE CUSTOMER STATED THAT HE HAD THE FLU AND INFECTION, WHICH MAY HAVE CAUSED THE HIGH BLOOD GLUCOSE. THE CUSTOMER ALSO STATED THAT HIS INSULIN PUMP WORKS FINE AND IT WAS NOT NECESSARY TO PERFORM ANY TROUBLESHOOTING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization