BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4202957 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-43657
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 27, 2014
    Report Date
    September 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    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. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RESERVOIR HAD OCCLUSION. CUSTOMER STATED THAT SHE COULD NOT PUSH THE INSULIN THROUGH THE TUBING. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 306 MG/DL. DURING THE TROUBLESHOOTING THE INSULIN EXITED THE TUBING AND INSULIN EXITED WITH THE MANUAL PRIME. ADVISED THE CUSTOMER TO REPORT BACK IF ISSUES PERSISTS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681654 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H9122677

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR