BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1002134 · Received February 25, 2008

    Report

    Report Number
    2032227-2008-00386
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 13, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    PMA / PMN Number
    K001628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER'S FATHER STATED THAT INSULIN LEAKED PAST THE O-RINGS. THE FATHER ALSO REPORTED A BLOOD GLUCOSE READING OF 460 MG/DL, WHICH THE CUSTOMER WOULD BE TREATING. 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 WE0806417

    Patients

    Seq Age Sex Outcome Treatment
    1