BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAB PRDGM INS V2.2 BL EN

    MDR report key: 1081820 · Received July 23, 2008

    Report

    Report Number
    3004209178-2008-00534
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 12, 2008
    Report Date
    July 12, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 400 MG/DL. THE CUSTOMER'S MOTHER STATED THE CUSTOMER HAD LARGE KETONES UPON BEING ADMITTED TO THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. IT WAS FOUND THAT THE CUSTOMER HAD LAST CHANGED THE INFUSION SET ON THE DAY OF THE EVENT. THE CUSTOMER'S MOTHER STATED THE CUSTOMER HAD JUST STARTED ON THE INSULIN PUMP THREE DAYS PRIOR TO THE EVENT. IT WAS ADVISED THAT THE CUSTOMER'S MOTHER SPEAK WITH THE CUSTOMER'S DOCTOR TO POSSIBLY ADJUST THE BASAL RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAB PRDGM INS V2.2 BL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization