BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1061650 · Received June 17, 2008

    Report

    Report Number
    2183996-2008-00875
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 6, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED HER INSULIN INFUSION SET TUBING BROKE AT THE CLIP WHERE THE TUBING CONNECTS TO THE HEADSET. SHE STATED SHE DID NOT KNOW HOW LONG THE TUBING HAD BEEN IN USE. SHE SAID, SHE HAD AN ELEVATED BLOOD GLUCOSE READING WHICH SHE CORRECTED BY CHANGING HER TUBING AND BOLUSING INSULIN. DURING TROUBLESHOOTING, THE PT STATED SHE CHANGES HER INFUSION HEADSET EVERY 3-4 DAYS AND HER TUBING EVERY 20 DAYS. THE PT WAS ADVISED THE RECOMMENDED TIME FOR CHANGE IS EVERY 2 DAYS FOR THE HEADSET AND EVERY 6 DAYS FOR THE TUBING. THE PT WAS SENT A COMPLIMENTARY GUIDE TO INFUSION SITE MGMT AND REPLACEMENT INFUSION SETS. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED 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 163687

    Patients

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