BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAL PRDGM INS CL EN US LN

    MDR report key: 1040211 · Received May 8, 2008

    Report

    Report Number
    2032227-2008-00792
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 27, 2008
    Report Date
    April 27, 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 INFORMATION 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 WITH HIGH BLOOD GLUCOSE LEVELS OVER 500 MG/DL AND KETONES. THE MOTHER STATES THAT THE CUSTOMER HAD BEEN COMPLAINING FOR SOME TIME ABOUT THE INSULIN PUMP SHOOTING OUT INSULIN THROUGH THE NEEDLE DURING THE MANUAL PRIME. ADVISED THE MOTHER THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization