BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1003001 · Received February 21, 2008

    Report

    Report Number
    2183996-2008-00195
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    February 9, 2008
    Report Date
    February 9, 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
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT AT APPROXIMATELY 2:20PM, HER BLOOD GLUCOSE WAS ELEVATED TO 220 MG/DL. SHE ATTEMPTED TO BOLUS 8 UNITS OF INSULIN, AND SHE RECEIVED AN OCCLUSION (E4) ERROR ON HER INFUSION DEVICE. SHE RECEIVED 3.7 UNITS OF INSULIN BEFORE THE ERROR AND THEN INJECTED THE REMAINDER OF THE BOLUS TO LOWER HER BLOOD GLUCOSE. SHE REPORTED THAT SHE RECEIVED A CORTISONE INJECTION IN HER FOOT THAT WAS CONTRIBUTING TO THE ELEVATED BLOOD GLUCOSE. TO TROUBLESHOOT THE PT WAS INSTRUCTED TO DISCONNECT FROM THE INFUSION SITE AND TO PERFORM A PRIME. SHE WAS ABLE TO DO SO WITHOUT ERROR. SHE WAS THEN INSTRUCTED TO PERFORM A 1.5 UNIT BOLUS. SHE WAS ABLE TO DO SO WITHOUT ERROR. SHE STATED THAT HER HEADSET HAD BEEN IN USE FOR 3-4 DAYS. SHE WAS ADVISED TO CHANGE THE HEADSET EVERY 3 DAYS. WHEN THE PT REMOVED THE HEADSET SHE STATED THAT THE CANNULA WAS BENT. THE PT INSERTED A NEW HEADSET, AND WAS ABLE TO BOLUS TO FILL THE CANNULA SPACE WITHOUT ERROR. UPON FOLLOW UP ON TWO DAYS LATER, THE PT STATED HER BLOOD GLUCOSE MEASURED 102 MG/DL. 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 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 7E193UF

    Patients

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