BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LWWB PRDGM INS BL EN LN

    MDR report key: 1812251 · Received August 20, 2010

    Report

    Report Number
    2032227-2010-82395
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 17, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS 20MMOL/L IN THE EVENING. THE NEXT MORNING, THE CUSTOMER FELT SICK AND WAS VOMITING. THE BLOOD GLUCOSE ROSE TO 22MMOL AND IT WAS TREATED WITH 8.4 UNITS. IT WAS STATED THAT THE CUSTOMER CONTINUED BEING SICK AND WAS TAKEN TO THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED, AND THE PROGRAMMING WAS CORRECT. THE SELF AND HIGH PRESSURE TESTS PASSED. THE INSULIN DROPPED OUT OF THE TUBING AND BOLUS AND BASAL MATCHED TO THE DAILY TOTALS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712LWWB PRDGM INS BL EN LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization