BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4133750 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-32027
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 17, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    CUSTOMER'S FATHER REPORTED RECEIVING SEVERAL NO DELIVERY ALARMS. HE STATED HE HAD TRIED TO PUSH INSULIN THROUGH THE TUBING AND WAS UNSUCCESSFUL. THE DAUGHTER'S BLOOD GLUCOSE WAS 425 MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTIONS. TROUBLESHOOTING DID NOT OCCUR. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611122 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC MINIMED MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR