BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1063162 · Received June 20, 2008

    Report

    Report Number
    2032227-2008-01034
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 7, 2008
    Report Date
    June 11, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 BEING HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS NOT REPORTED. THE CUSTOMER STATED THAT HE JUST WENT BACK ON THE INSULIN PUMP AND HIS BLOOD GLUCOSE WERE NOT GOING DOWN AFTER A BOLUS. TROUBLESHOOTING COULD NOT BE PERFORMED AT THE TIME OF THE CALL. NO FURTHER INFO WAS PROVIDED.

    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