BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722LNAP PRDGM INS PL EN ML

    MDR report key: 1874056 · Received October 15, 2010

    Report

    Report Number
    2032227-2010-82950
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    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

    THE CUSTOMER REPORTED THAT SHE HAS EXPERIENCED BENT CANNULAS, BUT THE INSULIN PUMP HAS NOT ALARMED NO DELIVERY. THE CUSTOMER DID NOT HAVE THE TUBING CLAMP FOR THE HIGH PRESSURE TEST AT THE TIME OF THE CALL. SENT THE CUSTOMER THE TUBING CLAMP, AND ADVISED TO CALL BACK TO CONDUCT THE TEST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR