BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515LNAP PRDGM INS V2.1 PL EN

    MDR report key: 1081811 · Received July 23, 2008

    Report

    Report Number
    2032227-2008-01279
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 13, 2008
    Report Date
    July 13, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    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 OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER STATED THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 353 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. THE INSULIN PUMP PASSED THE PRIME TEST. THE CUSTOMER'S MOTHER COULD NOT PERFORM THE HIGH PRESSURE TEST DURING THE INITIAL CALL; HOWEVER, THE CUSTOMER'S MOTHER CALLED BACK, AND THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. IT WAS ADVISED THAT THE CUSTOMER'S MOTHER DISCUSS THE SITUATION WITH THE CUSTOMER'S DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515LNAP PRDGM INS V2.1 PL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization