BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 3150927 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-94499
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. PLEASE SEE MEDWATCH REPORT # 3004209178-2013-94498.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INSULIN FROM THE RESERVOIR LEAKED INTO THE RESERVOIR COMPARTMENT. THE CUSTOMER WAS UNSURE IF THE LEAKS HAPPENED PAST THE O-RINGS. THE BLOOD GLUCOSE READING WAS 469MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250355 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H8599493

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR