BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715LNAL PRDGM INS V2.1 CL EN

    MDR report key: 1050269 · Received May 22, 2008

    Report

    Report Number
    2032227-2008-00877
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    May 11, 2008
    Report Date
    May 11, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 500 MG/DL. THE CUSTOMER THEN GOT ON THE PHONE AND STATED THAT HE WAS HAVING HIGH BLOOD GLUCOSE LEVELS AND WAS VOMITING THREE DAYS PRIOR TO THE HOSPITALIZATION. THE CUSTOMER DID NOT CHANGE THE INFUSION SET OR TAKE ANY ACTION UNTIL GOING TO THE HOSPITAL. THE CUSTOMER DID NOT FEEL WELL ENOUGH TO TROUBLESHOOT AND STATED THAT HE WOULD CALL BACK ONCE HE WAS FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715LNAL PRDGM INS V2.1 CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization