BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3850010 · Received June 4, 2014

    Report

    Report Number
    3004209178-2014-85431
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 NUMBERS ON THE INSULIN PUMP STARTED RAMPING WITHOUT THE CUSTOMER'S INTERVENTION AS IF THE BUTTONS WERE STUCK. THE CUSTOMER ALSO MENTIONED MOISTURE IN THE RESERVOIR COMPARTMENT, BUT IT WAS UNSURE IF IT WAS COMING FROM THE RESERVOIR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326662 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1