BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1812305 · Received August 20, 2010

    Report

    Report Number
    3004209178-2010-82595
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    March 26, 2010
    Report Date
    August 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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

    THE CUSTOMER REPORTED BEING HOSPITALIZED A FEW MONTHS AGO FOR HIGH BLOOD GLUCOSE OF OVER 600MG/DL. THE CUSTOMER STATED THAT HER GLUCOSE LEVEL CONTINUED BEEN ELEVATED. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE WERE CORRECT. THE CUSTOMER STATED THAT SHE WAS EXPERIENCING SOME SYMPTOMS OF NAUSEA, THIRST, AND KETONES. THE INSULIN PUMP WAS RECORDING THE BOLUSES AND BASALS PROPERLY IN THE DAILY TOTALS. RAN A FIXED PRIME AND HIGH PRESSURE TESTS AND PASSED. 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 LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization