BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2133690 · Received June 9, 2011

    Report

    Report Number
    2032227-2011-01399
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS TREATED BY THE PARAMEDICS WHILE SHE WAS AT THE GROCERY STORE. THE CUSTOMER WAS ABOUT TO PAY WHEN SHE NOTICED THAT SOMETHING WAS WRONG. THE CASHIER CALLED THE PARAMEDICS FOR ASSISTANCE. WHEN THEY ARRIVED, THE CUSTOMER'S BLOOD GLUCOSE READING WAS 29 MG/DL. THE CUSTOMER WAS TREATED, BUT NOT TAKEN TO THE HOSPITAL. THE CUSTOMER STATED THAT IT WAS A VERY HOT DAY, AND SHE WAS RUNNING ERRANDS. 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-515LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention