BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712NAB PRDGM INSULIN BL EN

    MDR report key: 1870124 · Received October 11, 2010

    Report

    Report Number
    2032227-2010-82901
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 380 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER FELT ILL AT HOME, AND WAS TAKEN TO URGENT CARE. THE CUSTOMER WAS SHOWING SIGNS OF DIABETIC KETOACIDOSIS, LIKE FRUITY BREATH. THE MOTHER HAD NO FURTHER INFO REGARDING THE EVENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712NAB PRDGM INSULIN BL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization