BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-754WWB PRDGM INS BL EN

    MDR report key: 1853361 · Received October 1, 2010

    Report

    Report Number
    3004209178-2010-82962
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. THE SETTINGS AND BASALS 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. DURING THE CALL, THE CUSTOMER STATED THAT SHE VISITED AN URGENT CARE THE DAY OF THE CALL. THE CUSTOMER WAS NOT ADMITTED. THE CUSTOMER WAS TOLD TO TAKE MORE INSULIN AND WAS RELEASED THE SAME DAY. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization