BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722WWL PRDGM INSULIN CL EN ML

    MDR report key: 1812255 · Received August 20, 2010

    Report

    Report Number
    3004209178-2010-82558
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 17, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 HOSPITALIZED FOR KETOACIDOSIS. ALSO, IT WAS REPORTED THAT THE BLOOD GLUCOSE WAS NORMAL THE DAY BEFORE, AND THE INFUSION SET WAS CHANGED TWO DAYS BEFORE THE HOSPITALIZATION. IT WAS STATED THAT WHEN THE INFUSION SET WAS REMOVED THE CANNULA WAS BENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization