BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722RNAB PRDGM INS BL EN RC

    MDR report key: 1873088 · Received October 15, 2010

    Report

    Report Number
    2032227-2010-82966
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 30, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS OF APPROXIMATELY 500MG/DL. THE CUSTOMER STATED THAT SHE WAS VERY TIRED. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE DAILY TOTALS WERE CORRECT AND THE SELF TEST PASSED. THE CUSTOMER DID NOT HAVE SUPPLIES TO CONTINUE WITH THE TROUBLESHOOTING. ADVISED THE CUSTOMER TO CALL BACK AS NEEDED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722RNAB PRDGM INS BL EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization