BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1241789 · Received November 20, 2008

    Report

    Report Number
    2183996-2008-01765
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 6, 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
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED RECURRING OCCLUSIONS ON HER INSULIN INFUSION DEVICE AND ELEVATED BLOOD GLUCOSE READINGS UP TO OVER 300 MG/DL. SHE STATED THIS HAS OCCURRED WITH THE LAST 4-5 CARTRIDGES. SYMPTOMS ARE WEAKNESS, LOSS OF APPETITE AND DRY HEAVES. SHE SAID SHE CORRECTS HER READINGS BY BOLUSING INSULIN THROUGH HER DEVICE AND, IF HER BLOOD GLUCOSE DOES NOT LOWER WITHIN 2 HOURS, SHE GIVES HERSELF AN INJECTION OF INSULIN. SHE STATED SHE JUST RECEIVED AN E4 (OCCLUSION) ALARM WHILE TRYING TO BOLUS 3.5 UNITS OF INSULIN. THE PATIENT WAS INSTRUCTED TO DISCONNECT FROM HER INFUSION HEADSET AND BOLUS 4 UNITS THROUGH THE TUBING WHICH WENT THROUGH WITHOUT ERROR. THE PATIENT CHANGED HER INFUSION HEADSET AND DISCOVERED THE CANNULA WAS SLIGHTLY BENT. SHE SAID IT HAD BEEN IN USE FOR 1.5 DAYS. SHE INSERTS HER HEADSETS BY HAND AND OCCASIONALLY 'HESITATES' WHEN INSERTING IT. THE PATIENT HAS BEEN ON PUMP THERAPY FOR 7 YEARS AND HAS ONLY INSERTED HER SITES BELOW THE NAVEL. SHE STATED SHE HAS SCAR TISSUE. SITE SELECTION AND MANAGEMENT WERE DISCUSSED WITH THE PATIENT. COURTESY INFUSION SETS, INSERTION DEVICE, AND A GUIDE TO SITE MANAGEMENT WERE SENT TO THE PATIENT. ON FOLLOW UP WITH THE PATIENT, SHE STATED SHE IS "DOING BETTER." SHE SAID SHE EXPERIENCED 1 MORE OCCLUSION AFTER THE CALL AND WHEN SHE REMOVED THE HEADSET, THE CANNULA WAS KINKED. SHE STATED SHE INSERTED A NEW HEADSET WITH NO FURTHER ISSUES. SHE STATED HER NEW SITE LOCATION IS ABSORBING WELL AND HER BLOOD GLUCOSE HAS STAYED WITHIN HER TARGET RANGE AND EVEN DROPPED TO 46 MG/DL THIS MORNING. SHE SAID SHE FELT SHAKY AND WEAK AND TREATED HER LOW READING BY EATING DIVINITY AND BY LUNCH HER READING HAD RETURNED TO HER TARGET READING OF 122. MG/DL. THE PATIENT RECEIVED THE COURTESY PRODUCTS. SITE ROTATION AND HOW TO USE THE INSERTION DEVICE WAS REVIEWED WITH THE PATIENT. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL 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 7F006UF

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention INSULIN INFUSION PUMP| INSULIN