BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 3760187 · Received April 18, 2014

    Report

    Report Number
    3004209178-2014-83797
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED RESERVOIR. PERFORMED LEAK TEST AND RESERVOIR PASSED PER SPECIFICATIONS. NO OCCLUSION OR LEAKAGE ANOMALY NOTED DURING ANALYSIS. CHECKED O-RINGS AND STOPPER GROOVE FOR DEFECTS AND NONE WERE FOUND. RESERVOIR CONNECTED AND LOCKED INTO PLACE PROPERLY.

    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 RETURN FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HER RESERVOIR LEAKED INSULIN FROM THE BOTTOM OF RESERVOIR PAST BOTH OF THE O-RING WHILE MANUALLY PUSHING THE INSULIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237546 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR