BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4221456 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46644
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING NO DELIVERY. CUSTOMER STATES THEY ARE UNABLE TO PERFORM TROUBLESHOOTING DUE TO ALREADY CHANGING OUT THE ENTIRE SET. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LED TO THE ALARM OR IF THE DEVICE WAS DROPPED. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 231 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701696 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG00LZ9

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR