BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1081822 · Received July 23, 2008

    Report

    Report Number
    3004209178-2008-00536
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 OF 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 800 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. IT WAS FOUND THAT THE CUSTOMER HAD RECEIVED A NO DELIVERY ALARM, BUT HAD NOT CHANGED OUT HIS INFUSION SET. IT WAS ADVISED THAT THE CUSTOMER CHANGE THE INFUSION SET WHENEVER HE RECEIVES A NO DELIVERY ALARM. IT WAS ALSO FOUND THAT THE CUSTOMER CHANGES THE INFUSION SET EVERY FIVE DAYS. THE PROPER SET CHANGE PROCEDURE WAS EXPLAINED TO THE CUSTOMER'S MOTHER. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization