BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1063316 · Received June 18, 2008

    Report

    Report Number
    3004209178-2008-00423
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. THE CUSTOMER HAS BEEN IN AND OUT OF THE HOSP FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 545MG/DL. A DAY LATER, THE DIABETES MGMT CONSULTANT CALLED AND STATED THAT THE CUSTOMER CAME TO THE HOSP WITHOUT THE INSULIN PUMP AND IT HAPPENED MANY TIMES WHERE HE WOULD REMOVE THE PUMP AND THEN BE ADMITTED TO THE HOSP FOR UNCONTROLLED HIGH BLOOD GLUCOSE.

    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 Hospitalization