BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    MDR report key: 1882329 · Received October 21, 2010

    Report

    Report Number
    2032227-2010-83027
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 328 MG/DL. THE CUSTOMER EXPERIENCED SWEATING AND DRY HEAVES. THE CUSTOMER STATED THAT SHE CHANGED THE INFUSION SET THE DAY BEFORE THE EVENT, AND WHEN THE INFUSION SET WAS REMOVED, THERE WAS NO CANNULA. THE NURSES DIDN'T FEEL THAT IT BROKE OFF INSIDE THE CUSTOMER'S BODY. THEY FELT THAT THE CANNULA WAS NEVER THERE. THE CUSTOMER CHANGED THE INFUSION SET, AND HER BLOOD GLUCOSE LEVELS WENT BACK TO NORMAL. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization