BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1231661 · Received November 14, 2008

    Report

    Report Number
    2183996-2008-01722
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE HAS EXPERIENCED ELEVATED BLOOD GLUCOSE FOR THE PAST MONTH DUE TO KINKED INFUSION SET CANNULAS. HER BLOOD GLUCOSE HAS BEEN AS HIGH AS 700 MG/DL AND SHE HAS FELT "DEADLY ILL" WITH NAUSEA, CONFUSION, AND DIFFICULTY SEEING. HER NORMAL BLOOD GLUCOSE LEVEL IS 120 MG/DL. ONE DAY PRIOR, HER BLOOD GLUCOSE ELEVATED TO OVER 600 MG/DL AND SHE INJECTED 5 UNITS OF INSULIN AND CHANGED HER INFUSION SITE. THIS MORNING HER BLOOD GLUCOSE MEASURED 130 MG/DL. SHE STATED THAT SOME DAYS SHE MUST CHANGE THE INFUSION SITE UP TO 5 TIMES BEFORE SHE HAS GOOD INSULIN ABSORPTION. SHE ONLY USED HER "BELLY AREA" AS AN INFUSION SITE AND SHE HAS A LOT OF SCAR TISSUE. SHE WAS EDUCATED ON ALTERNATIVE INFUSION SITES. SHE WAS SENT INFUSION SETS WITH A LONGER CANNULA LENGTH, AN INFUSION SITE INSERTION DEVICE, AND INFO ON INFUSION SITE MGMT. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 8A037UF

    Patients

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