BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722RNAB PRDGM INS BL EN RC

    MDR report key: 1873069 · Received October 15, 2010

    Report

    Report Number
    2032227-2010-82924
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 25, 2010
    Report Date
    September 25, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 461 MG/DL. IT WAS STATED THAT THE CUSTOMER EXPERIENCED BENT CANNULAS PRIOR TO THE EVENT. IT WAS ALSO STATED THAT THE CUSTOMER WEARS THE INFUSION SETS FOR SIX DAYS. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. ADVISED TO ONLY WEAR THE INFUSION SETS FOR TWO TO THREE DAYS. 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 72 YR Hospitalization