BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4801359 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-59844
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 6, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION WAS PERFORMED ON ONE USED AND OPENED RESERVOIR. THE TRANSFER GUARD NEEDLE WAS FOUND BENT AT A 90 DEGREE ANGLE. THE TESTING COULD NOT BE PERFORMED DUE TO THE BENT NEEDLE. IT COULD NOT BE CONFIRMED IF THE CUSTOMER RECEIVED THE TRANSFER GUARD NEEDLE BENT DUE TO THE PRODUCT BEING RETURNED OPENED AND USED.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A NEEDLE BREAK IN THEIR RESERVOIR. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE RESERVOIR WILL BE RETURNED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347689 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG020YU

    Patients

    Seq Age Sex Outcome Treatment
    1