BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSVR MMT-326A 10PK PRDGM 1.8ML 13L

    MDR report key: 1214025 · Received October 23, 2008

    Report

    Report Number
    2032227-2008-01835
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING ANALYSIS, IT WAS FOUND THAT THE O-RINGS ON THE RESERVOIR WERE OUT OF GROOVE, CAUSING THE RESERVOIR TO LEAK. IT COULD NOT BE CONFIRMED IF THE CUSTOMER RECEIVED THE RESERVOIR DAMAGED BECAUSE THE RESERVOIR WAS RETURNED OPENED AND USED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE O-RINGS WERE NOT POSITIONED PROPERLY INSIDE THE RESERVOIR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-326A 10PK PRDGM 1.8ML 13L DISPOSABLES FMF MEDTRONIC MINIMED MMT-326A WI1507538

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR