BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAP PRDGM INSULIN PURPLE EN

    MDR report key: 1873068 · Received October 15, 2010

    Report

    Report Number
    3004209178-2010-83134
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 11, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 IN THE EMERGENCY ROOM FOR HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS IN THE 600S MD/GL PRIOR GOING TO THE HOSPITAL. THE CUSTOMER STATED THAT SHE CHANGED THE INFUSION SET CHANGE AND HER GLUCOSE LEVEL WENT UP. THE CUSTOMER WAS VOMITING AND SHE WAS GIVEN FLUIDS AND INSULIN. TROUBLESHOOTING WAS PERFORMED. THE TIME ON THE INSULIN PUMP WAS CORRECT. REVIEWED THE DAILY TOTALS AND FOUND THAT THE DEVICE WAS SUSPENDED FOR APPROX TWO HOURS. 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-723NAP PRDGM INSULIN PURPLE EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization