BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSVR MMT-332A 10PK PRDGM 3CC 14L

    MDR report key: 1812063 · Received August 18, 2010

    Report

    Report Number
    3004209178-2010-82526
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FMF
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED THREE RANDOM SEALED RESERVOIRS AND THREE OPENED USED RESERVOIRS. MANUAL PRIME TEST 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE MOTHER STATED THAT SHE CHANGED THE RESERVOIRS SEVERAL TIMES AND THE INSULIN PUMP ALARMED REPEATEDLY NO DELIVERY. NO FURTHER INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-332A 10PK PRDGM 3CC 14L RESERVOIR FMF MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A H7653644

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization