BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3243863 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-95970
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 18, 2013
    Report Date
    July 18, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    INSPECTED THREE RANDOM SEALED RESERVOIRS, PERFORMED MANUAL PRIME AND HIGH-PRESSURE TEST PER SPECIFICATIONS, USING A NEW INFUSION SET ALONG WITH THE INSULIN PUMP, THE RESERVOIRS PASSED PER SPECIFICATIONS. NO LEAKAGE ANOMALY NOTED DURING ANALYSIS. INSPECTED O-RINGS ON THE STOPPER GROOVE FOR DEFECTS AND NO ANOMALIES WERE FOUND. ALL RESERVOIRS CONNECTED/LOCKED IN PLACE PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN FROM THE RESERVOIR LEAKED DURING NORMAL USE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344111 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H8709851

    Patients

    Seq Age Sex Outcome Treatment
    1