BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAB PRDGM INS BL EN US LN

    MDR report key: 1031861 · Received April 16, 2008

    Report

    Report Number
    2032227-2008-00652
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 2, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 PROD 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 HIGH BLOOD GLUCOSE LEVELS BETWEEN 600 AND 700 MG/DL. THE CUSTOMER WAS ALSO NAUSEOUS AND VOMITING. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE MOTHER DID NOT HAVE THE TUBING CLAMP FOR THE HIGH PRESSURE TEST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization