BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2090919 · Received May 2, 2011

    Report

    Report Number
    2032227-2011-01118
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2011-01119.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR ASSISTANCE WITH AN INFUSION SET CHANGE. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READING WAS 405 MG/DL, BUT SHE WAS TOO WEAK TO TREAT HERSELF. THE PARAMEDICS WERE CALLED FOR ASSISTANCE. THEY ARRIVED AT HER HOUSE, AND TREATED THE CUSTOMER. ASSISTED THE PARAMEDICS WITH THE INFUSION SET CHANGE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention