BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1013643 · Received March 13, 2008

    Report

    Report Number
    2183996-2008-00332
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 3, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K033892
    Removal / Correction Number
    Z-1116/1146-6
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT STATED THAT HER INSULIN TUBING SEPARATED AT THE LUER CONNECTION ON TWO DAYS EARLIER, AND HER BLOOD GLUCOSE ELEVATED TO 480 MG/DL AND SHE FELT "ROTTEN" AND HAD A HEADACHE. SHE CHANGED THE INFUSION TUBING, HEADSET, AND CARTRIDGE AND BOLUSED 6 UNITS OF INSULIN TO LOWER HER BLOOD GLUCOSE. LATER IN THE NIGHT HER BLOOD GLUCOSE DECREASED TO 262 MG/DL. THE INFUSION TUBING HAD BEEN IN USE SINCE ON THE MONTH BEFORE. SHE STATED THAT SHE HAS EXPERIENCED SEPARATED INFUSION TUBING 6-7 TIMES IN THE LAST "COUPLE" OF MONTHS. SHE STATED SHE CHANGES HER HEADSET EVERY 3-4 DAYS AND HER INFUSION TUBING ONCE A WEEK. SHE WAS ADVISED TO CHANGE HER HEADSET EVERY 3 DAYS AND HER INFUSION TUBING EVERY 6 DAYS. SHE REPORTED HER BLOOD GLUCOSE MEASURED 24 MG/DL THE MORNING OF ORIGINAL DATE, AND SHE DRANK ORANGE JUICE. SHE STATED THAT SHE "HAS TROUBLE WITH IT IN THE MORNINGS." HER NORMAL BLOOD GLUCOSE LEVEL IS 150 MG/DL. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    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 6H113UF

    Patients

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