BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715LNAB PRDGM INS V2.1 BL EN

    MDR report key: 1161650 · Received September 15, 2008

    Report

    Report Number
    2032227-2008-01594
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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'S FATHER STATED THAT THE CUSTOMER WAS HOSPITALIZED AS A RESULT OF HYPERGLYCEMIA AND THE FLU. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE PRIME TEST PASSED, BUT THE HIGH PRESSURE TEST FAILED. IT WAS ADVISED THAT THE HIGH PRESSURE TEST BE PERFORMED AGAIN WITH A NEW INFUSION SET AND RESERVOIR. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization