BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1020679 · Received March 28, 2008

    Report

    Report Number
    2183996-2008-00407
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 14, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED AN ELEVATED BLOOD GLUCOSE READING OF 560 MG/DL WITH HER NORMAL RANGE BEING 126 - 200 MG/DL. SHE SAID SHE FEELS "HOT, GOOEY AND STICKY" AND SHE TREATED HER READING BY TAKING AN INJECTION OF INSULIN. SHE STATED SHE HAS NOT BEEN ABLE TO GET INSULIN BECAUSE HER INSULIN INFUSION SET TUBING IS "KINKED." SHE STATED THERE IS NO APPARENT DAMAGE TO THE TUBING AND SHE CAN NOT VISUALLY SEE ANYTHING WRONG WITH IT. SHE SAID SHE HAS TO CHANGE HER TUBING WHEN SHE CHANGES HER HEADSET OR THIS ISSUE OCCURS. THE PATIENT STATED SHE DISCONNECTED FROM HER HEADSET AND PRIMED, BUT NO INSULIN CAME OUT. SHE SAID SHE THEN DISCONNECTED THE TUBING FROM HER INSULIN INFUSION DEVICE [COMPETITOR PRODUCT] AND PRIMED WITHOUT ERROR. ON FOLLOW-UP, THE PATIENT STATED SHE CHANGED HER TUBING AND HER BLOOD GLUCOSE READINGS HAVE BEEN 130 AND 150 MG/DL WHICH IS WITHIN HER NORMAL RANGE. THE PATIENT DID NOT REQUIRE 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 ACCU-CHEK RAPID D INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 142337

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R INSULIN INFUSION PUMP| INSULIN