BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723PNAS PRDGM INS V2.3 SK EN PW

    MDR report key: 1931202 · Received December 10, 2010

    Report

    Report Number
    2032227-2010-83405
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 20, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 REPORTED THAT SHE WAS HOSPITALIZED FOR BLOOD GLUCOSE LEVELS ABOVE 600 MG/DL. THE CUSTOMER ALSO REPORTED NO DELIVERY ALARMS. PRIOR TO THE EVENT, THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS FOR TWO DAYS, AS WELL AS TROUBLE BREATHING. THE CUSTOMER WAS USING A DIFFERENT INSULIN PUMP AT THE TIME OF THE CALL. NO TROUBLESHOOTING WAS DONE ON THE INSULIN PUMP BEING WORN AT THE TIME OF THE EVENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723PNAS PRDGM INS V2.3 SK EN PW INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723PNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization