BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722RNAP PRDGM INS PL EN RC

    MDR report key: 1881511 · Received October 19, 2010

    Report

    Report Number
    2032227-2010-83010
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 STATED THAT THE INSULIN PUMP WAS DELIVERING TOO MUCH INSULIN, SO SHE REMOVED IT WHILE SHE WAS ON A BOAT. THE CUSTOMER WAS UNABLE TO FIND THE INSULIN PUMP AFTER THAT. THE CUSTOMER STATED THAT SHE WOULD LOOK FOR IT AND CALL BACK AS NEEDED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR