BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3121176 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93770
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED THREE RANDOM SEALED RESERVOIRS AND ONE OPEN/USED RESERVOIR. MANUAL PRIME AND HIGH-PRESSURE TEST WERE PERFORMED AND ALL THE RESERVOIRS PASSED THE TESTS. NO LEAKS OR DEFECTS IN THE O-RINGS WERE OBSERVED DURING ANALYSIS AND ALL THE RESERVOIRS PASSED PER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INSULIN FROM THE RESERVOIR LEAKED PAST THE O-RINGS AND INTO THE RESERVOIR COMPARTMENT. THE BLOOD GLUCOSE READING WAS 311MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222828 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H8486688

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR