BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3632781 · Received February 18, 2014

    Report

    Report Number
    1823260-2014-01083
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    February 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K122686
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO A MISHANDLING OF THE PRODUCT BY THE CUSTOMER. THE USED RETURNED TRANSFER SET WAS VISUALLY INSPECTED. THE USED TRANSFER SET WAS FOUND DISCONNECTED FROM THE LUER. CHARACTERISTIC DISCOLORATION WAS FOUND ON THE TUBE NEAR BY THE CONNECTOR WHICH ARISES WHEN THE USER APPLIED TOO MUCH FORCE ON THE TUBE/CONNECTOR CONNECTION. REVIEW OF THE COMPLAINT RECORDS SHOWED NO OTHER COMPLAINTS OF RELEVANCE FOR LOT NUMBER 5043327.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2014, PATIENT REPORTED THE INFUSION SET TUBE SEPARATED FROM THE LUER LOCK. HER BLOOD GLUCOSE 389 MG/DL, AND SHE INSPECTED THE INFUSION SET AND NOTICED THE OUTER PORTION OF THE TUBE HAD DISCONNECTED. SHE GENTLY TUGGED ON THE INNER TUBE, AND THAT DISCONNECTED FROM THE LUER LOCK AS WELL. HER TARGET BLOOD GLUCOSE IS 90-140 MG/DL, AND SHE DELIVERED A MANUAL BOLUS OF INSULIN TO TREAT HYPERGLYCEMIA. THE INFUSION SET TUBE HAD BEEN IN USE FOR 6 DAYS. THE INFUSION SET WAS REPLACED AND REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101694 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5043327

    Patients

    Seq Age Sex Outcome Treatment
    1 044 YR NOVALOG| CONTINUOUS BLOOD GLUCOSE METER