BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1873051 · Received October 15, 2010

    Report

    Report Number
    3004209178-2010-83123
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 7, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING ADMITTED IN THE INTENSIVE CARE UNIT FOR DEHYDRATION CAUSED BY THE HIGH BLOOD GLUCOSE AND VOMITING. THE BLOOD GLUCOSE READING WAS 590 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HE CHANGES THE INFUSION SET EVERY THREE DAYS. THE CUSTOMER ALSO STATED THAT HE NOTICED SLIGHT DISCOLORATION IN THE INFUSION SET TUBING. RAN A FIXED PRIME 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-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization