BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1060739 · Received June 11, 2008

    Report

    Report Number
    2032227-2008-00969
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 28, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS STATED THAT INSULIN LEAKED PAST THE O-RINGS OF THE RESERVOIR. IT WAS ALSO STATED THAT THE CUSTOMER'S BLOOD GLUCOSE READING WAS 450 MG/DL. 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-322A

    Patients

    Seq Age Sex Outcome Treatment
    1