BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1122180 · Received August 15, 2008

    Report

    Report Number
    2032227-2008-01400
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTION BETWEEN THE INFUSION SET AND THE RESERVOIR WAS TOO LOOSE, CAUSING INSULIN TO LEAK FROM THE BOTTOM OF THE RESERVOIR. IT WAS REPORTED THAT THE CUSTOMER HAD THROWN AWAY THE RESERVOIR THAT HAD LEAKED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1