BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAS PRDGM INS V2.1 SK EN

    MDR report key: 1133286 · Received August 21, 2008

    Report

    Report Number
    3004209178-2008-00642
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    August 10, 2008
    Report Date
    August 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO A URINARY TRACT INFECTION AND DIABETIC KETOACIDOSIS. TROUBLESHOOTING WAS PERFORMED, AND IT WAS FOUND THAT THE CUSTOMER WAS RECEIVING AN ALARM ON THE INSULIN PUMP. IT WAS ADVISED THAT THE CUSTOMER DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACKUP PLAN TO TREAT HIS DIABETES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization