BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2171125 · Received July 11, 2011

    Report

    Report Number
    2032227-2011-01708
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    May 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 THE BASAL RATE SETTINGS. THE CUSTOMER WAS CALLING FROM THE HOSPITAL, WHERE SHE HAD BEEN FOR (B)(6) DUE TO COMPLICATIONS OF GASTROPARESIS. THE CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 224 MG/DL. 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-715LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization