BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 3051700 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-92472
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESERVOIRS WERE RECEIVED STILL IN THEIR UN-OPENED STERILE PACKAGES. THE RESERVOIR WAS REMOVED FROM ITS STERILE PACKAGE AND EXAMINED. ALL PARTS WERE PRESENT; BOTH O-RINGS WERE ON THE STOPPER. THE PLUNGER ROD WAS CYCLED BACK IN FORTH DRY; SLIDING FRICTION WAS PRESENT AND FELT NORMAL. DELIVERY FORCE EQUIPMENT WAS NOT AVAILABLE TO MEASURE THE SLIDING-FRICTION AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESERVOIR WAS FILLED WITH 70-80 UNITS. WHILE PRIMING THE CUSTOMER NOTICED IT ONLY TOOK 2.7 UNITS WHEN INSULIN STARTED TO DRIP OUT OF THE NEEDLE AT THE END OF THE TUBING. THE CALLER EXPECTED AROUND 8 TO 9 UNITS OF INSULIN BEFORE SEEING INSULIN DRIP OUT OF THE TUBING. HOWEVER, THE INSULIN STOPPED PRIMING AND INSULIN KEPT DRIPPING OUT OF THE INTRODUCER NEEDLE. THE CALLER STATED THAT THE PISTON NEVER TOUCHED THE BACK OF THE RESERVOIR OR STOPPER DURING THE PRIMING PROCESS. IT WAS STATED THAT THE CUSTOMER WOKE UP FEELING HIS BLOOD GLUCOSE WAS LOW, BUT HE WENT BACK TO BED. THE NEXT MORNING WHEN HE WOKE UP IT WAS NOTICED THAT THE RESERVOIR WAS EMPTY. ADVISED THE CALLER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148543 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H8461538

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR