BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-508UC EA INSULIN CH EN US

    MDR report key: 1031554 · Received April 18, 2008

    Report

    Report Number
    2032227-2008-00670
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 6, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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 STATED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE CUSTOMER REPORTED A BLOOD GLUCOSE READING OF 380 MG/DL DURING THE PHONE CALL. THE CUSTOMER STATED THAT SHE DID NOT GIVE A MANUAL INJECTION WHEN HER BLOOD GLUCOSE LEVELS BEGAN TO ELEVATE. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE LEADSCREW AND SELF TESTS. THE CUSTOMER DID NOT HAVE THE TUBING CLAMP FOR THE HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-508UC EA INSULIN CH EN US INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508UC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization