BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-523NAB PRDGM INSULIN BLUE

    MDR report key: 1812048 · Received August 18, 2010

    Report

    Report Number
    3004209178-2010-82532
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 400 MG/DL. IT WAS STATED THAT THE CUSTOMER WOKE UP VOMITING AND HAD POSITIVE KETONES. THE MOTHER ALSO STATED THAT A HEALTH CARE PROFESSIONAL ADVISED TO TAKE THE CUSTOMER TO THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED. THE MOTHER MENTIONED THAT THE CUSTOMER HAD EXPERIENCED A LOT OF ISSUES WITH BENT CANNULAS. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-523NAB PRDGM INSULIN BLUE INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization