BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1082206 · Received July 25, 2008

    Report

    Report Number
    2183996-2008-01099
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 13, 2008
    Report Date
    July 13, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED BLOOD GLUCOSE READING OF 463 MG/DL. THE PATIENT SAID, HIS SYMPTOM WAS NAUSEA AND HE TREATED HIS READINGS BY TAKING AN INSULIN INJECTION. HE STATED HE HAS HAD 2 BENT INSULIN INFUSION SET CANNULAS TODAY AND THAT OVER THE LAST YEAR HAS HAD 1 OUT OF EVERY 4-5 CANNULAS BEND. HE SAID HE HAS USED HIS BUTTOCKS FOR HIS INFUSION SITE FOR 14 YEARS. HE STATED, HE HAS SCAR TISSUE THERE BUT IS RELUCTANT TO TRY ANOTHER AREA. SITE ROTATION WAS DISCUSSED WITH THE PATIENT AND A COMPLIMENTARY GUIDE TO SITE MANAGEMENT, AN INSERTION DEVICE, AND A BOX OF INFUSION SETS WERE SENT TO THE PATIENT. THE PATIENT DID NOT REQUIRE 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 UNK

    Patients

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