BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4241581 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50088
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE RESERVOIR LEAKED AROUND THE RUBBER GUM, THE BOTTOM GUM OF IT. CUSTOMER REPORTED HE ATTEMPTED TO BOLUS AND HE NOTICE THAT RESERVOIR LEAKED. CUSTOMER ATTEMPTED TO USE TWO RESERVOIRS FROM THE SAME LOT NUMBERS. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER REPORTED THE LEAKS ONLY OCCURRED WHEN CUSTOMER ATTEMPTED TO BOLUS. CUSTOMER WAS ADVISED TO CLEAN RESERVOIR COMPARTMENT ON THE INSULIN PUMP. CUSTOMER WAS ADVISED TO PERFORM SELF TEST, TEST WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721645 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H9019563

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR