BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4230061 · Received October 11, 2014

    Report

    Report Number
    2032227-2014-37020
    Event Type
    Malfunction
    Date Received
    October 11, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    NO BLOOD GLUCOSE LEVELS REPORTED. THE CUSTOMER REPORTED THAT THERE WAS A LEAK FROM THE INFUSION SET DURING PRIMING FOR THE INSULIN PUMP. THE CUSTOMER REPORTED THAT THE MOTOR OF THE INSULIN PUMP WAS NOT RUNNING SINCE NO NOISE COULD BE HEARD BUT THE INSULIN CONTINUED TO DRIP FROM THE INFUSION SET. NO INFORMATION WAS PROVIDED AS TO THE EXACT MAKE AND MODEL OF THE INFUSION SET THAT WAS LEAKING. THE CUSTOMER WAS ALSO ADVISED THAT THE RESERVOIR OF THE INSULIN PUMP MIGHT BE OCCLUDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645459 RESERVOIR 3ML FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-322A

    Patients

    Seq Age Sex Outcome Treatment
    1