BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1033047 · Received April 22, 2008

    Report

    Report Number
    2032227-2008-00695
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 17, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    PMA / PMN Number
    K032005
    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 INITIALLY CALLED TO REPORT HIGH BLOOD GLUCOSE LEVELS. PRIOR TO TROUBLESHOOTING, THE CUSTOMER NOTICED THAT INSULIN WAS LEAKING FROM THE TUBING AND RESERVOIR CONNECTION. THE CUSTOMER STATED THAT SHE WOULD CHANGE THE ENTIRE INFUSION SET. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-332A 10PK PRDGM 3CC 14L RESERVOIR FMF MEDTRONIC MINIMED MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1