BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1055819 · Received June 2, 2008

    Report

    Report Number
    2183996-2008-00805
    Event Type
    Injury
    Date Received
    June 2, 2008
    Date of Event
    March 21, 2008
    Report Date
    May 21, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEM
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE (240-285 MG/DL) DUE TO INSULIN LEAKAGE FROM THE INFUSION SET. HE STATED THAT HE HAS EXPERIENCED OCCASIONAL ELEVATED BLOOD GLUCOSE OVER THE PAST TWO MONTHS. HE BOLUSES TO LOWER HIS BLOOD GLUCOSE. ON THE SAME DAY, HE NOTICED THAT THE ADHESIVE OF THE INFUSION SET WAS WET. HE ALSO NOTICES "HARD SPOTS OR LUMPS" AT THE AREA OF THE INFUSION SITE WHEN THE SITE IS REMOVED AND PAIN DURING BOLUSES. HE CHANGES THE INFUSION SET EVERY TWO DAYS. THE PATIENT WAS SENT REPLACEMENT INFUSION SETS AND TEGADERM DRESSINGS. UPON FOLLOW UP THE PATIENT STATED THAT THE TEGADERM DRESSINGS ARE HELPING TO REDUCE PAIN AND IRRITATION AT THE INFUSION SITE. HE STATED HE WILL BEGIN USING THE SIDE OF HIS ABDOMEN AS AN INFUSION SITE BECAUSE THE SKIN TISSUE IS SOFTER. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS 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 SYSTEM NA 033767

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION PUMP| INSULIN