BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3972254 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88770
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN OCCLUSION. THE CUSTOMER STATED THAT WHEN THEY WERE CHANGING THE INFUSION SET THE INSULIN PUMP ALARMED NO DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE WAS 115 MG/DL. THE CUSTOMER STATED THAT THEY CHANGED SIX RESERVOIRS AND INFUSION SETS, DONE TROUBLESHOOTING, BUT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER STATED THAT THEY BELIEVE THE PROBLEMATIC RESERVOIRS AND INFUSION SETS WERE ALL FROM THE SAME LOT NUMBER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447721 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H9113684

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR