BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1063312 · Received June 19, 2008

    Report

    Report Number
    3004209178-2008-00426
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 7, 2008
    Report Date
    June 7, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 520 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE DEVICE PASSED FIXED PRIME TEST AND THE INSULIN EXITED. THE TOTALS AND BASAL RATES WERE CORRECT. UPON RECEIVING THE TUBING CLAMP A HIGH-PRESSURE TEST WAS PERFORMED AND PASSED. NO FURTHER INFO WAS PROVIDED.

    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 OPERATONS MED-REL MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization