BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1062707 · Received June 16, 2008

    Report

    Report Number
    2032227-2008-00997
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 2, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 MOTHER INITIALLY CALLED TO REPORT THAT THE INSULIN PUMP WAS ALARMING AND SHE WANTED TO KNOW HOW TO TURN IT OFF. THE MOTHER THEN STATED THAT THE CUSTOMER WAS HOSPITALIZED AND TREATED FOR LOW BLOOD GLUCOSE LEVELS. NO BLOOD GLUCOSE READING WAS REPORTED. THE MOTHER STATED THAT THE CUSTOMER WAS ALSO SUFFERING FROM OTHER MEDICAL ISSUES NOT RELATED TO THE INSULIN PUMP. THE MOTHER STATED THAT THE CUSTOMER'S PEDIATRICIAN WAS GOING TO TAKE HER OFF THE INSULIN PUMP FOR NOW. THE MOTHER STATED THAT SHE WOULD BE CALLING BACK FOR TROUBLESHOOTING IF NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization