BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4162020 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36080
    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
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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

    IT WAS REPORTED THAT THE CUSTOMER CANNOT GET HER INFUSION SET TO DELIVER. WHEN CUSTOMER GOES TO THE HOME SCREEN, IT SAYS LAST ALARM 12.24, NO DELIVERY, AND FINISH LOADING. CUSTOMER WAS CHANGING HER INFUSION SET WHEN THE ALARM OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200 MG/DL. CUSTOMER WAS ADVISED TO DISCONNECT THE TUBING AND RESERVOIR AND THEN RECONNECT. CUSTOMER STATED THAT THE INSULIN DID NOT EXIT. CUSTOMER WAS ABLE TO TROUBLESHOOT FOR A POTENTIAL RESERVOIR AND INFUSION SET AT THIS TIME. CUSTOMER WAS ASSISTED WITH PRIMING PUMP, BUT PUMP SAID NO DELIVERY. CUSTOMER STATED THAT THE INSULIN DID NOT EXIT THE TUBING. CUSTOMER TRIED ANOTHER RESERVOIR BUT THE PUMP ALARMED NO DELIVERY WITH MANUAL PRIME. CUSTOMER WAS ADVISED TO CHANGE THE RESERVOIR TO RESOLVE THE ISSUE AND TO RETURN THE RESERVOIR. CUSTOMER WAS ABLE TO PRIME AND INSERT INFUSION SET. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643860 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H9083607

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR