BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAL PRDGM INSULIN CLEAR EN

    MDR report key: 1853362 · Received October 1, 2010

    Report

    Report Number
    3004209178-2010-82964
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 11, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    THE CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE OF 41MG/DL. THE PARAMEDICS WERE CALLED AND TREATED THE CUSTOMER'S GLUCOSE LEVEL. TROUBLESHOOTING WAS PERFORMED. THE SETTINGS, BASAL, AND DAILY TOTALS WERE CORRECT. THE UNITS LEFT ON THE STATUS SCREEN MATCHED TO THE UNITS LEFT IN THE RESERVOIR. PERFORMED A DISPLACEMENT 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-723NAL PRDGM INSULIN CLEAR EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention