BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAS PRDGM INS SK EN US LN

    MDR report key: 1020966 · Received March 28, 2008

    Report

    Report Number
    2032227-2008-00567
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    March 16, 2008
    Report Date
    March 17, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW, ONCE THE ANALYSIS HAS BEEN COMPLETED. 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. THE MOTHER REPORTED A BLOOD GLUCOSE READING OF 341 MG/DL DURING THE PHONE CALL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE PRIME TEST WAS PERFORMED AND THE MOTHER STATED, SHE DIDN'T SEE VERY MUCH INSULIN COMING OUT. THE CUSTOMER WAS UNCOMFORTABLE WITH THE INSULIN PUMP AND WANTED IT REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization