BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 2190317 · Received July 20, 2011

    Report

    Report Number
    3004209178-2011-82228
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 5, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE SEALED RESERVOIR AND TWO OPENED USED RESERVOIRS. MANUAL PRIME AND HIGH-PRESSURE TEST WERE PERFORMED AND THE RESERVOIRS PASSED THE TESTS. NO LEAKS OR DEFECTS IN THE O-RINGS WERE OBSERVED DURING ANALYSIS AND ALL THE RESERVOIRS WERE CONNECTED AND LOCKED IN PLACE PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 455MG/DL. THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR THE PAST WEEK. THE CUSTOMER STATED THAT IT SEEMS THE INSULIN PUMP WAS NOT DELIVERING INSULIN WHEN HE DISCONNECTED AND DELIVERED A BOLUS OF 1.5 UNITS. THE CUSTOMER CHANGED THE INFUSION SET AND RESERVOIR, AND HE STILL DID NOT GET ANY INSULIN. THE CUSTOMER STATED THAT HE TREATED WITH MANUAL INJECTION AND HIS GLUCOSE LEVEL DECREASED. THE CUSTOMER STATED THAT HE KEPT USING THE INSULIN PUMP, BUT HIS BLOOD GLUCOSE WAS HIGH, AND HE WENT TO THE EMERGENCY ROOM. THE CUSTOMER STATED THAT HE CHANGED THE INFUSION SET AND RESERVOIR FROM ANOTHER BOX AND SINCE THEN HIS BLOOD GLUCOSE HAS BEEN STABLE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A H7764774

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization