BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712WWL PRDGM INSULIN CL EN

    MDR report key: 2954218 · Received April 19, 2007

    Report

    Report Number
    3004209178-2007-04708
    Event Type
    Injury
    Date Received
    April 19, 2007
    Date of Event
    March 23, 2007
    Report Date
    April 16, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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 STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. IT WAS ALSO STATED THAT THE CUSTOMER DROPPED THE INSULIN PUMP ONTO THE FLOOR THREE DAYS PRIOR TO THE HOSPITALIZATION. IN ADDITION, IT WAS STATED THAT THE CUSTOMER CHANGED THE INFUSION SET SEVERAL TIMES PRIOR TO THE HOSPITALIZATION BUT HIGH BLOOD GLUCOSE LEVELS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712WWL PRDGM INSULIN CL EN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-712WWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization