BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-754WWS PRDGM INS SK EN

    MDR report key: 1842915 · Received September 17, 2010

    Report

    Report Number
    3004209178-2010-82830
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    September 11, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF OVER 300MG/DL. IT WAS STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WENT UP TO 365MG/DL FOR THE PAST TWO WEEKS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. THE BASALS AND BOLUSES MATCHED TO THE DAILY TOTALS. HOWEVER, THE DOCTOR DELIVERED A BOLUS OF 50 UNITS AND THE INSULIN DID NOT EXIT. THE HIGH PRESSURE TEST WAS PERFORMED SEVERAL TIMES AND THE DEVICE FAILED THE TEST. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-754WWS PRDGM INS SK EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization