BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4123329 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29511
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE WAS 131 MG/DL. TROUBLESHOOTING WAS PERFORMED AND INSULIN DID NOT EXIT THE INFUSION SET TUBING WHILE INSULIN WAS BEING MANUALLY PUSHED WITH A PLUNGER. THE CUSTOMER USED A NEW RESERVOIR WITH THE SAME INFUSION SET AND INSULIN DID EXIT THE TUBING WHICH SOLVED THE ISSUE. THE INSULIN PUMP DID NOT ALARM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602511 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A H8826886

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR