BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAP PRDGM INS PL EN US LN

    MDR report key: 1031539 · Received April 18, 2008

    Report

    Report Number
    2032227-2008-00666
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 4, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS WITH A BLOOD GLUCOSE READING OF 822 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST. NO FURTHER TESTING WAS PERFORMED AS THE MOTHER FELT THAT THE INSULIN PUMP WAS WORKING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512LNAP PRDGM INS PL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization