BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIFTY50 1.8 ML RESERVOIR

    MDR report key: 2382015 · Received November 1, 2011

    Report

    Report Number
    3004145981-2011-00002
    Event Type
    Malfunction
    Date Received
    November 1, 2011
    Date of Event
    October 29, 2010
    Report Date
    November 1, 2010
    Manufacturer
    APPLIED DIABETES RESEARCH, INC.
    Product Code
    FRN
    PMA / PMN Number
    K041152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE LUER DID NOT TIGHTEN DOWN, ALLOWING INSULIN TO LEAK OUT DURING A BOLUS. THE USER CONJECTURED THAT THE USER MAY NOT BE RECEIVING A FULL DOSE OF INSULIN DURING A BOLUS. IT WAS REPORTED THAT THE TISSUE CAME OUT WET WHEN STICKING THE CORNER OF A TISSUE INTO THE CONNECTOR AREA AND SMELLED OF INSULIN. THE LUER LOCK ALSO PULLED STRAIGHT OFF THE RESERVOIR IF IT WAS CAUGHT ON SOMETHING E.G. A HAND OR AN ARM. UNLESS THE PATIENT NOTICED THAT THE TUBING HAD BECOME DISCONNECTED, THE USER COULD HAVE BEEN WITHOUT INSULIN UNTIL THE TUBING IS RECONNECTED. THE LUER LOCK FILLS WITH INSULIN AND MIGHT HAVE ALLOWED BUBBLES TO ENTER DURING THE PRIMING PROCESS. THE BUBBLES GET INTO THE TUBING, WHICH COULD HAVE LEFT THE USER MISSED INSULIN FOR SOMETIMES. EACH TIME THE USER USED THE RESERVOIR, THE USER REPORTED BLOOD SUGAR READINGS THAT WERE IN THE HIGH 200'S AND WOULD NOT COME DOWN. WHEN ASKED, THE USER SAID NO OTHER INTERVENTIONS WERE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIFTY50 1.8 ML RESERVOIR INFUSION PUMP SYRINGE FRN APPLIED DIABETES RESEARCH, INC. 1850 75922

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR