BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 3251093 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-96153
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER IS WEARING ONE OF THE EFFECTED LOT NUMBERS FROM THE RECALL. THE CUSTOMER WAS ADVISED NOT TO WEAR THESE RESERVOIRS. IT WAS STATED THAT THE CUSTOMER TESTED HER BLOOD GLUCOSE AND THE BLOOD GLUCOSE METER JUST SAID "HIGH". THE CUSTOMER WAS THROWING LARGE KETONES AND SHE IS ON THE WAY TO THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352243 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization