BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAS PRDGM INSULIN SMOKE EN

    MDR report key: 1931047 · Received December 8, 2010

    Report

    Report Number
    3004209178-2010-83553
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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

    CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF OVER 400 MG/DL. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 270 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE BASAL, BOLUS HISTORY, AND ALARM HISTORY ON THE INSULIN PUMP WERE CORRECT. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND THE DEVICE PASSED THE TEST. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723NAS PRDGM INSULIN SMOKE EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization