BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-511LNAL PRDGM INS CL EN US LN

    MDR report key: 1791809 · Received August 4, 2010

    Report

    Report Number
    2032227-2010-82153
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K001829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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

    THE CUSTOMER STATED THAT HALF OF THE INSULIN THAT WAS IN THE RESERVOIR, WAS ACCIDENTALLY DELIVERED INTO HER BODY DURING THE MANUAL PRIME. THE CUSTOMER WAS IN A CAR AT THE TIME OF THE CALL, AND HER BLOOD GLUCOSE LEVELS DROPPED TO 51 MG/DL. THE CUSTOMER TREATED ON HER OWN, BUT HER HUSBAND DROVE HER TO THE NEAREST EMERGENCY ROOM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-511LNAL PRDGM INS CL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-511LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization