BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2070249 · Received April 18, 2011

    Report

    Report Number
    2032227-2011-00944
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 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 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 CALLED FOR ASSISTANCE WITH HER GLUCOSE METER. THE CUSTOMER THEN REPORTED FEELING SHAKY AND STATED THAT SHE NEEDED INSULIN. THE CUSTOMER LEFT THE PHONE TO FIND ANOTHER GLUCOSE METER. WHEN SHE CAME BACK, SHE FORGOT WHO SHE WAS TALKING ON THE PHONE WITH. AT THAT TIME THE PARAMEDICS WERE CALLED AND ADVISED TO GO TO THE CUSTOMER'S HOME FOR ASSISTANCE. THE PARAMEDICS ARRIVED AND HUNG UP THE PHONE. ATTEMPTED TO CALL BACK BUT GOT NO ANSWER. 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