BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3951363 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-88088
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    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 CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSPECTED RESERVOIR, SNAP-CAP AND SEPTUM FOR ANOMALIES NONE WERE FOUND. PERFORMED OCCLUSION TEST PER SPECIFICATIONS, RESERVOIR FILLED AND CONNECTED TO NEW INFUSION SET. INSTALLED RESERVOIR AND CONNECTOR INTO INSULIN PUMP AND PERFORMED INFUSION SET. INSTALLED RESERVOIR AND CONNECTOR TO INSULIN PUMP AND PERFORMED CATHETER TIP. RESERVOIR NOT OCCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN LEAKED INTO THE RESERVOIR COMPARTMENT FROM THE RESERVOIR BARREL. THE CUSTOMER'S BLOOD GLUCOSE WAS 260 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP, TO REMOVE THE RESERVOIR AND TO DRY THE RESERVOIR COMPARTMENT WITH A LINT FREE CLOTH OR STERILE GAUZE. THE CUSTOMER STATED THAT THEY USED NAPKIN AND THERE WERE NO DEBRIS LEFT OVER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428447 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H8489386

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR