BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712RNAB PRDGM INS BL EN US RC

    MDR report key: 1870144 · Received October 11, 2010

    Report

    Report Number
    2032227-2010-82922
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 26, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LGZ
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC COMA, STROKE, AND VOMITING. THE CUSTOMER HAD A BLOOD GLUCOSE READING AS HIGH AS 1100. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712RNAB PRDGM INS BL EN US RC INFUSION PUMP LGZ MEDTRONIC MINIMED MMT-712RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization