BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2072509 · Received April 21, 2011

    Report

    Report Number
    2032227-2011-00986
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    February 6, 2011
    Report Date
    April 8, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE AND PARAMEDICS WERE CALLED. THE BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 23 MG/DL. CUSTOMER STATED THAT THE PARAMEDICS TREATED THE LOW BLOOD GLUCOSE AT HOME. CUSTOMER STATED THAT SHE HAS A CHEST X-RAY AND SHE WAS WEARING THE INSULIN PUMP. PERFORMED THE DISPLACEMENT TEST AND THE TEST FAILED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention