BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1840880 · Received September 17, 2010

    Report

    Report Number
    2032227-2010-82676
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 29, 2010
    Report Date
    August 29, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM FOR DIABETIC KETOACIDOSIS. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. AFTER BEING RELEASED FROM THE HOSPITAL, THE CUSTOMER WENT BACK ON THE INSULIN PUMP AND STATED THAT HIS BLOOD GLUCOSE LEVELS ELEVATED AGAIN. THE CUSTOMER STATED THAT THE CANNULAS ARE SOMETIMES BENT WHEN REMOVING THE INFUSION SET. SENT SAMPLES OF DIFFERENT INFUSION SETS FOR THE CUSTOMER TO TRY. 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 67 YR Hospitalization