BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712RNAP PRDGM INS PL EN US RC

    MDR report key: 1180073 · Received September 26, 2008

    Report

    Report Number
    2032227-2008-01667
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 13, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 102MG/DL. THE CUSTOMER STATED THAT THE PARAMEDICS WERE CALLED BECAUSE HER BLOOD GLUCOSE WAS LOW. THE NEXT DAY, THE CUSTOMER WAS ADMITTED IN THE HOSPITAL. TROUBLESHOOTING WAS NOT PERFORMED BECAUSE THE CUSTOMER KNOWS THAT SHE OVER BOLUSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712RNAP PRDGM INS PL EN US RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization