BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4032722 · Received August 25, 2014

    Report

    Report Number
    3004209178-2014-97325
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    ONE SEALED RESERVOIR ONE INSPECTED AND A VISUAL INSPECTION WAS PERFORMED. THE TRANSFER GUARD NEEDLE CENTER WAS FOUND OFF.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN SHE DISCONNECTED THE RESERVOIR FROM NEEDLE GUARD, SHE NOTICED THAT THE WHITE CAP ON RESERVOIR IS CROOKED. CUSTOMER WAS ADVISED TO CHANGE THE RESERVOIR AND TO JUST TWIST AND PULL STRAIGHT UP ON RESERVOIR WHEN DISCONNECTING FROM THE TRANSFER GUARD. BLOOD GLUCOSE 67 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512187 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG04NBZ

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR