BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 4040726 · Received August 27, 2014

    Report

    Report Number
    1823260-2014-06531
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 16, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTED RECEIVING AN E4 (OCCLUSION) ERROR MESSAGE. PATIENT CHANGED HER INFUSION SITE; THE CANNULA WAS BENT. PATIENT STATED HER READINGS WERE HIGHER THAN SHE LIKES TO KEEP THEM. PATIENT REPORTED HER READING WAS 245 MG/DL. PATIENT ALLEGES THE ELEVATED READINGS ARE BECAUSE OF A BENT CANNULA. PATIENT STATED SHE BOLUSED TO BRING THE READINGS DOWN AND ALSO CHANGED THE INFUSION SITE. PATIENT REPORTED THE INFUSION SITE WAS WET AND THE INFUSION SET HAS LEAKED. PATIENT STATED THE CANNULAS HAVE BENT AND CAUSED INSULIN TO LEAK BACK OUT INSTEAD OF INTO HER BODY. PATIENT REPORTED SHE HAS DISPOSED OF THE LEAKY INFUSION SETS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED INFUSION SET CANNULA FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520027 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5043084

    Patients

    Seq Age Sex Outcome Treatment
    1