BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4161899 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36088
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    CUSTOMER REPORTED A NO DELIVERY ALARM DURING A PRIME. THE CUSTOMER'S BLOOD GLUCOSE WAS 200 MG/DL. THE CUSTOMER WAS ASSISTED WITH PERFORMING A 5 UNIT FIXED PRIME AND IT WAS FOUND THE CUSTOMER WAS UNABLE TO COMPLETE THE PRIME. IT WAS ALSO FOUND INSULIN WAS NOT ABLE TO EXIT. THE CUSTOMER REPORTED INSULIN WAS ABLE TO EXIT FROM THE TUBING WITH A PLUNGER PUSH. HE ALSO REPORTED THAT INSULIN WAS ABLE TO EXIT WITH A MANUAL PRIME. THE CUSTOMER WAS ADVISED THAT HIS INFUSION SET OR RESERVOIR MAY BE OCCLUDED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643520 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR