BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4132278 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31031
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (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. 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

    CUSTOMER REPORTED THAT WHILE TROUBLESHOOTING THE INSULIN PUMP FOR MOTOR ERROR, HER RESERVOIR LEAKED INTO THE INSULIN PUMP AND SHE COULD SMELL INSULIN. BLOOD GLUCOSE VALUE IS 118 MG/DL. CUSTOMER STATED THE LEAK OCCURRED WHEN CUSTOMER REMOVED RESERVOIR FROM THE INSULIN PUMP. CUSTOMER STATED SHE CANNOT SEE WHERE THE INSULIN DRIPPED BUT IS ABLE TO SMELL IT. CUSTOMER STATED THAT THERE IS A SCRATCH MARK ON THE RESERVOIR. CUSTOMER REPORTED THAT SHE HAS BEEN EXPERIENCING HIGH BLOOD GLUCOSE BUT ATTRIBUTES IT TO INSULIN LEAKING OUT OF THE RESERVOIR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612156 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR