BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1202822 · Received October 14, 2008

    Report

    Report Number
    2183996-2008-01583
    Event Type
    Injury
    Date Received
    October 14, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 3, 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

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT FOR A FEW YEARS SHE REC'D REPEATED OCCLUSION MESSAGES ON HER INSULIN INFUSION DEVICE WITH HER INFUSION SETS. SHE STATED HER NORMAL BLOOD GLUCOSE RANGE IS 90-135 MG/DL BUT WHEN SHE GETS OCCLUSIONS, HER READINGS ELEVATE TO THE 400 MG/DL TO "HI" RANGE. SHE SAID SHE CORRECTS HER ELEVATED READINGS WITHIN A FEW HRS BY CHANGING HER INFUSION HEADSET AND TUBING AND BOLUSING INSULIN. THE PT STATED SHE HAS TRIED 3 DIFFERENT INSULINS BUT THE ISSUE HAS CONTINUED. THE PT STATED SHE BELIEVES THE OCCLUSION IS IN THE TUBING WHEN SHE DISCONNECTS FROM HER HEADSET AND TRIES TO BOLUS THROUGH THE TUBING, SHE STILL RECEIVES AN OCCLUSION MESSAGE. SHE THEN DETACHES THE TUBING AND CAN BOLUS THROUGH THE ADAPTER WITHOUT ERROR. SHE STATES SHE ATTACHES A NEW TUBING WHICH RESOLVES THE ISSUE FOR A FEW DAYS. SHE SAID SHE NORMALLY CHANGES HER TUBING EVERY 5 DAYS TO AVOID OCCLUSIONS. DURING TROUBLESHOOTING, THE PT STATED SHE IS USING THE LONGER TUBING AND LIVES IN A WARM ENVIRONMENT. THE PT WAS ADVISED TO TRY A SHORTER TUBING TO MINIMIZE THE TIME THE INSULIN IS EXPOSED IN THE TUBING. COMPLIMENTARY INFUSION SETS WERE SENT TO THE PT. THE PT SAID THE ADAPTER ON HER INFUSION DEVICE HAS NOT BEEN CHANGED IN SEVERAL MONTHS. SHE WAS ADVISED IT SHOULD BE CHANGED WITH EVERY 10TH CARTRIDGE CHANGE. THE PT DID NOT RETAIN ANY AFFECTED INFUSION SETS TO RETURN. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS AVAILABLE TO BE RETURNED FOR EVAL.

    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 033767

    Patients

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