BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3M

    MDR report key: 4210578 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43325
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REQUESTED ASSISTANCE WITH CHANGING HIS INFUSION SET. IT WAS FOUND INSULIN WAS LEAKING WHILE THE CUSTOMER WAS CHANGING HIS INFUSION SET. TROUBLESHOOTING WAS ABLE TO RESOLVE THE ISSUE. THE CUSTOMER ALSO REPORTED A HIGH BLOOD GLUCOSE OF 441 MG/DL. THE CUSTOMER STATED HE WOULD TREAT HIS BLOOD GLUCOSE. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680627 RESERVOIR 3M FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR