BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4183025 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39981
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A POSSIBLE OCCLUSION ON THE RESERVOIRS AND INFUSION SET. BLOOD GLUCOSE READING WAS 87 MG/DL. THE CUSTOMER WAS PERFORMING A SET CHANGE WHEN THE PLUNGER WOULD NOT PUSH INSULIN TO THE TUBING. THE RESERVOIR AND TUBING CONNECTOR WERE IN PLACE WHEN THIS OCCURRED. CUSTOMER STATED THE SAME SITUATION HAD OCCURRED ONE WEEK AGO. THE CUSTOMER MENTIONED THAT THIS SITUATION CAUSED HER BLOOD GLUCOSE TO GO HIGH. ADVISED TO RETURN THE INFUSION SET AND RESERVOIRS FOR ANALYSIS. THE INFUSION SET AND RESERVOIRS WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662228 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG04NBZ

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR