BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712WWL PRDGM INSULIN CL EN

    MDR report key: 1032854 · Received April 22, 2008

    Report

    Report Number
    2032227-2008-00692
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 15, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. 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

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND A BLOOD GLUCOSE READING OF 240 MG/DL. IT WAS STATED THAT THE CUSTOMER CHANGED THE INFUSION SET ON THE MORNING OF THE HOSPITALIZATION. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention