BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8 ML MMT-326A

    MDR report key: 2023133 · Received February 15, 2011

    Report

    Report Number
    3004209178-2011-80428
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 5, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE CONTINUOUSLY. THE CUSTOMER STATED HAVING PROBLEMS WITH P-CAPS FROM THE RESERVOIRS BEING TOO TIGHT OR TOO LOOSE. THE CUSTOMER STATED THAT INSULIN WAS LEAKING AT THE TRANSFER GUARD, PAST THE O-RINGS, AND INSIDE THE RESERVOIR COMPARTMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 1.8 ML MMT-326A RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-326A H7763027

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR