BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712WWB PRDGM INSULIN BL EN PR

    MDR report key: 1771953 · Received July 22, 2010

    Report

    Report Number
    3004209178-2010-82141
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    July 18, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K031390
    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 DID NOT FEEL WELL IN THE MORNING, HAD BREATHING PROBLEMS, FELL DIZZINESS, AND WAS VOMITING. THE CUSTOMER STATED THAT SHE FELT THE SAME SYMPTOMS IN THREE DIFFERENT OCCASIONS. THE SUGAR LEVEL WAS OVER 27MG/DL. THE CUSTOMER WAS RUSHED TO THE HOSPITAL AND THEY REMOVED THE DEVICE. THE CUSTOMER ALSO STATED THAT THE DEVICE DID NOT REVEAL PLAYING A PART IN THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712WWB PRDGM INSULIN BL EN PR INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-712WWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization