BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1120953 · Received August 13, 2008

    Report

    Report Number
    2183996-2008-01209
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 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
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT SHE WAS AWOKEN BY THE INFUSION DEVICE ALARMING E4 (OCCLUSION). SHE STATED THAT SHE CHANGED THE INFUSION SET AND INSULIN CARTRIDGE. SHE STATED THAT THE INFUSION SET APPEARED TO BE BROKEN AT THE LUER CONNECTION. THE INFUSION DEVICE CONTINUED TO ALARM E4 DURING PRIMING. SHE WAS ABLE TO PRIME THE INFUSION SET WITHOUT ERROR WHEN DISCONNECTED FROM THE INFUSION SITE. SHE CHANGED THE INFUSION SITE 2 TIMES AND CONTINUED TO RECEIVED E4 ERRORS. THE PATIENT WAS INSTRUCTED TO PERFORM THE CHANGE CARTRIDGE PROCEDURE, AND THE INFUSION DEVICE CONTINUED TO OCCLUDE WHILE ATTACHED TO THE INFUSION SITE. SHE STATED THAT THE NEEDLE AT THE "PIGTAIL" CONNECTION APPEARED TO BE BENT AND SHE FELT SOME "RESISTANCE" WHILE TRYING TO CONNECT THE TWO PIECES. THE PATIENT SWITCHED TO A DIFFERENT TYPE OF INFUSION TUBING AND WAS ABLE TO PRIME WITHOUT ERROR. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID D INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 461395

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN