BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 4200033 · Received October 24, 2014

    Report

    Report Number
    1823260-2014-08242
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 7, 2014
    Report Date
    January 28, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INFUSION SET LEAKED INSULIN AND THIS RESULTED IN HYPERGLYCEMIA OF 510 MG/DL. HER TARGET BLOOD GLUCOSE IS 140-150 MG/DL, AND SHE CHANGED THE CARTRIDGE AND INFUSION SET AND SUCCESSFULLY DELIVERED A 10.0 UNIT BOLUS. SHE EXPERIENCED SYMPTOMS OF FREQUENT URINATION, CHEST PAIN, AND FEELING LETHARGIC. THE LEAK OCCURRED NEAR THE CANNULA UNDER THE SELF-ADHESIVE. FOLLOW-UP WAS COMPLETED ON (B)(6) 2014, AND SHE REPORTED ANOTHER INFUSION SET FROM THE SAME BOX LEAKED INSULIN. THE CANNULA WAS SLIGHTLY BENT BUT SHE WAS UNABLE TO SEE ANY BREAKS OR TEARS. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION, AND SHE WAS SENT INFUSION SETS WITH LONGER CANNULAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679246 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5022155

    Patients

    Seq Age Sex Outcome Treatment
    1