BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID D INFUSION SET

    MDR report key: 1001256 · Received February 19, 2008

    Report

    Report Number
    2183996-2008-00171
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 20, 2008
    Report Date
    January 22, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S DAUGHTER REPORTED THE PATIENT HAS RECEIVED AN 04 (OCCLUSION) MESSAGE ON HER INSULIN INFUSION DEVICE. DURING TROUBLESHOOTING, THE PATIENT'S DAUGHTER STATED THE PATIENT CHANGES HER INFUSION SET EVERY 2-3 DAYS. SHE WAS ADVISED IT SHOULD BE CHANGED EVERY 2 DAYS. SHE STATED SHE NOTICED AIR BUBBLES NEAR THE LUER LOCK DURING THE TIME THE INFUSION DEVICE DISPLAYED THE OCCLUSION MESSAGE. SHE SAID THE PATIENT HAS HAD OCCLUSIONS DURING PRIMING WITH 4 BOXES OF HER INFUSION SETS. NO BLOOD GLUCOSE CONCERNS WERE REPORTED RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID D INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS RAPID D 034346

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP