BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4243740 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50448
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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

    IT WAS REPORTED THAT THE NO DELIVERY ALARMS WERE RECEIVED ON THE CUSTOMER'S INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONNECT AND RECONNECT TUBING AND RESERVOIR AND PUSH INSULIN THROUGH WITH A PLUNGER. THE CUSTOMER VERIFIED THAT NO INSULIN WAS EXITING. THE CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE SET. THE CUSTOMER'S BLOOD GLUCOSE WAS NOT KNOWN, BUT HAD BEEN 8.2 MMOL/L THE PREVIOUS NIGHT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727406 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG05M83

    Patients

    Seq Age Sex Outcome Treatment
    1