BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAS PRDGM INS SK EN ML

    MDR report key: 1821167 · Received August 26, 2010

    Report

    Report Number
    2032227-2010-82459
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 4, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE CUSTOMER'S WIFE STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR BLOOD GLUCOSE LEVELS ABOVE 300 MG/DL. THE CUSTOMER STATED THAT HE WAS BOLUSING, BUT HIS BLOOD GLUCOSE LEVELS CONTINUED TO ELEVATE. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAS PRDGM INS SK EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization