BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4090371 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23064
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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 SHE WAS RECEIVING NO DELIVERY ALARMS ON HER INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. WHILE EXECUTING A 5.0 UNIT FIXED PRIME, THE CUSTOMER STATED INSULIN EXITED AND THE PUMP ALARMED NO DELIVERY. HE CUSTOMER WAS ADVISED TO REMOVE THE RESERVOIR FROM THE INSULIN PUMP, AND TO DISCONNECT AND RECONNECT BOTH THE RESERVOIR AND THE INFUSION SET AT THE TUBING CONNECTOR AND PUSH INSULIN THROUGH THE TUBING. THE CUSTOMER REPORTED THAT INSULIN DID NOT EXIT WITH THE PLUNGER PUSH, INDICATING A POSSIBLE OCCLUSION. IT WAS EXPLAINED TO THE CUSTOMER THAT THE ALARM WAS CAUSED BY THE INFUSION SET AND RESERVOIR CONNECTION. IT WAS ADVISED FOR THE CUSTOMER TO REPLACE BOTH. HER BLOOD GLUCOSE WAS 231 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568982 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR