BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP MMT-712WWS

    MDR report key: 2170695 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-82136
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    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 WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF MORE THAN 500MG/DL. IT WAS STATED THAT THE CUSTOMER STARTED VOMITING AND THE BLOOD GLUCOSE METER WAS SHOWING HIGH. IT WAS STATED THAT THE PARAMEDICS WERE CALLED AND TOOK THE CUSTOMER TO THE HOSPITAL WHERE HE GOT AN INFUSION SET AND TREATED WITH INSULIN THAT HE WAS USING AT THE TIME. IT WAS STATED THE CUSTOMER GOT PNEUMONIA THE DAY AFTER BEING AT THE HOSPITAL. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP MMT-712WWS INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-712WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization