BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515NAS PRDGM INS V2.1 SK EN

    MDR report key: 1211150 · Received October 24, 2008

    Report

    Report Number
    2032227-2008-01850
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 15, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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 STATED THAT SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READING WAS OVER 500 MG/DL. THE CUSTOMER STATED THAT SHE HAS BEEN INSERTING HER INFUSION SETS BY HAND AND FEELS THAT HER INSERTION TECHNIQUE IS INCORRECT. THE CUSTOMER DID NOT TRY TO CHANGE HER INFUSION SET PRIOR TO BEING ADMITTED TO THE HOSPITAL. THE CUSTOMER ALSO STATED THAT SHE IS SUFFERING FROM THE STOMACH FLU AND A SORE THROAT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515NAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization