BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722WWS PRDGM INSULIN SK EN ML

    MDR report key: 1864746 · Received October 5, 2010

    Report

    Report Number
    3004209178-2010-83042
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 4, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 OF 775MG/DL. IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS TREATED WITH THE INSULIN PUMP, AND THE GLUCOSE READING WAS 280MG/DL. HOURS LATER, THE CUSTOMER BLOOD GLUCOSE WAS HIGHER. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722WWS PRDGM INSULIN SK EN ML INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization