BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712NAS PRDGM INSULIN SK EN

    MDR report key: 1032832 · Received April 21, 2008

    Report

    Report Number
    2032227-2008-00678
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 23, 2008
    Report Date
    April 8, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 580 MG/DL. THE CUSTOMER STATED THAT ON THE NIGHT PRIOR TO THE HOSPITALIZATION HE ATE TWO PIZZAS AND HE BOLUSED FOR THE FOOD. THE CUSTOMER STATED THAT HE WOKE UP WITH A BLOOD GLUCOSE READING OF 300 MG/DL. THE CUSTOMER CHANGED THE INFUSION SET, BUT A FEW HOURS LATER, HE WAS VOMITING AND SPILLING KETONES. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP ALSO PASSED THE PRIME AND HIGH PRESSURE TESTS. ADVISED THE CUSTOMER TO INSERT THE INFUSION SETS IN ANOTHER PART OF THE BODY AS HE IS ONLY USING HIS BUTTOCKS, WHERE HE HAS A LOT OF SCAR TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712NAS PRDGM INSULIN SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization