BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4090439 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23129
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF 1 OPENED AND USED RESERVOIR SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT INSULIN LEAKED INTO THE RESERVOIR COMPARTMENT. CUSTOMER STATED THAT THEY HAVE ALSO BEEN EXPERIENCING HIGH BLOOD GLUCOSE READINGS OF 454 MG/DL DUE TO THE LEAK AND HAVE BEEN TREATING WITH A MANUAL INJECTION. CUSTOMER STATED THAT THEY NOTICED THEIR BLOOD GLUCOSE READINGS GOING UP AND SMELLED INSULIN PRIOR TO THE CALL. CUSTOMER FURTHER STATED THAT THE INSULIN WAS SEEPING THROUGH THE BOTTOM OF THE RESERVOIR AND THROUGH THE O RINGS. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568795 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A H7487135

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR