BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3222971 · Received July 12, 2013

    Report

    Report Number
    2032227-2013-02864
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    March 1, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    PATIENT

    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

    CUSTOMER CALLED TO REPORT A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT SHE HAD AN ISSUE WITH THE CANNULA WHICH CAUSE THE HOSPITALIZATION. THE CURRENT BLOOD GLUCOSE READING IS 300 MG/DL. CUSTOMER HAS TREATED WITH INSULIN PUMP. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 975 MG/DL. THE PARAMEDICS WERE CALL TO TRANSPORT CUSTOMER TO HOSPITAL. CUSTOMER STATED THAT SHE WAS DISORIENTED. DIAGNOSED DIABETIC KETOACIDOSIS. CUSTOMER STATED THAT THE CANNULA WAS BENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321858 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization