BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 1081818 · Received July 23, 2008

    Report

    Report Number
    3004209178-2008-00531
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 STATED SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER STATED AFTER EATING, HER BLOOD GLUCOSE WAS HIGH AND SHE FELT QUEASY. THE CUSTOMER STATED SHE TESTED HIGH FOR KETONES AND BEGAN VOMITING, SO SHE WENT TO THE EMERGENCY ROOM. THE CUSTOMER'S DOCTOR STATED THE HOSPITALIZATION MAY HAVE BEEN PUMP-RELATED. THE CUSTOMER WAS UNABLE TO PERFORM TROUBLESHOOTING DURING THE INITIAL CALL, BUT THE CUSTOMER WAS ABLE TO CALL BACK AND PERFORM TROUBLESHOOTING. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAS PRDGM INS V2.2 SK EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization