BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723RNAS PRDGM INS V2.3 SK EN RC

    MDR report key: 1870125 · Received October 11, 2010

    Report

    Report Number
    2032227-2010-82903
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 23, 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 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 REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 833 MG/DL. IT WAS STATED THAT THE CUSTOMER HAD JUST STARTED ON THE INSULIN PUMP SIX DAYS EARLIER. TROUBLESHOOTING WAS PERFORMED, AND THE ALARM HISTORY HAD NO DELIVERY AND NO RESERVOIR ALARMS. THE WIFE REMOVED THE INFUSION SET, AND THE CANNULA WAS BENT. 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-723RNAS PRDGM INS V2.3 SK EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization