BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1082208 · Received July 25, 2008

    Report

    Report Number
    2183996-2008-01102
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 29, 2008
    Report Date
    July 1, 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
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON 07/01/08, THE PATIENT REPORTED THAT SHE RECEIVED SEVERAL E4 (OCCLUSION) MESSAGE ON HER INSULIN INFUSION DEVICE. SHE SAID THAT IN 2008, SHE WOKE UP TO AN E4 MESSAGE AND HER BLOOD GLUCOSE READING WAS 490 MG/DL. SHE STATED HER NORMAL BLOOD GLUCOSE RANGE IS 70-110 MG/DL. SYMPTOMS WERE RAPID BREATHING, NAUSEA AND FREQUENT URINATION. SHE SAID SHE IMMEDIATELY CHANGED HER INFUSION HEADSET AND TUBING AND PRIMED HER INFUSION DEVICE WITHOUT ERROR. SHE STATED WHEN SHE TRIED TO PERFORM A BOLUS, THE DEVICE ONCE AGAIN GAVE AN E4 MESSAGE. SHE STATED SHE CHANGED HER INFUSION SET SEVERAL MORE TIMES UNTIL SHE RAN OUT OF INFUSION SETS BUT THE ISSUE CONTINUED. THE FOLLOWING DAY, THE PATIENT WENT TO HER DOCTOR FOR THE ELEVATED BLOOD GLUCOSE AND FOR A PRESCRIPTION FOR INJECTION THERAPY. THE PATIENT'S BLOOD GLUCOSE LEVELS DURING THE CALL WERE WITHIN HER NORMAL RANGE. THE PATIENT DISCARDED THE INFUSION SETS AT ISSUE AND DID NOT HAVE ANY AVAILABLE FOR TROUBLESHOOTING. SITE MANAGEMENT WAS DISCUSSED WITH THE PATIENT AND A COURTESY INSERTION DEVICE AND REPLACEMENT INFUSION SETS WERE SENT. FURTHER ATTEMPTS TO FOLLOW UP WERE UNSUCCESSFUL. THE PRODUCT WAS REPLACED. NO PRODUCT WAS AVAILABLE 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 7K260UF

    Patients

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