BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522RNAL PRDGM INS CL EN RC

    MDR report key: 1912611 · Received November 23, 2010

    Report

    Report Number
    2032227-2010-83253
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 THE SECOND TIME DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF OVER 800MG/DL. IT WAS STATED WHEN THE INFUSION SET WAS REMOVED IT WAS FOUND THAT THE CANNULA WAS BENT ON TOP OF THE SKIN AND THERE WAS NO SIGN OF INSERTION POINT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522RNAL PRDGM INS CL EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization