BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3133314 · Received May 29, 2013

    Report

    Report Number
    2183996-2013-00913
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 13, 2013
    Report Date
    September 5, 2013
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT DESCRIBING A LEAKY ON THE HEAD SET CANNOT BE VERIFIED, THE HEAD SET MEETS PRODUCT SPECIFICATIONS. RESULT NO SAMPLES WERE RETURNED FOR INVESTIGATION; HOWEVER, THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. PATIENT DISCARDED THE INFUSION SET.

    Description of Event or Problem · 1

    ON (B)(6) 2013 PATIENT REPORTED HE HAS BEEN FACING LEAKING AT THE INFUSION SITE. PATIENT STATED THIS HAS BEEN OCCURRING FOR THE LAST MONTH OR SO. PATIENT REPORTED HE WILL TAKE HIS BLOOD GLUCOSE LEVEL AND WILL NOTICE IT IS ELEVATED. PATIENT STATED HE WILL THEN INSPECT HIS INFUSION SITE AND NOTICE LEAKING AT THE SITE. PATIENT REPORTED HE DOES NOT THINK IT IS HIS BODY, HE THINKS IT IS THE INFUSION SET. PATIENT REPORTED FACING A READING OF 194 MG/DL LAST NIGHT AND HE NOTICED LEAKING AT THE INFUSION SITE. PATIENT STATED HE CHANGED THE INFUSION HEADSET AND BOLUSED, AND THEN HIS MORNING HIS BLOOD GLUCOSE WAS BACK IN TARGET RANGE. PATIENT'S TARGET RANGE IS 90-130 MG/DL. PATIENT REPORTED THE CANNULAS HAVE NOT BEEN BENT OR KINKED UPON REMOVAL. PATIENT STATED HE HEARS AN AUDIBLE CLICK WHEN ATTACHING THE INFUSION SET TUBING TO THE HEADSET. PATIENT DISCARDED THE ALLEGED INFUSION SET. PATIENT REPORTED MOST OF THE INFUSION SETS HE HAS HAD CONCERN WITH HAVE BEEN OUT OF THE SAME BOX. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED; NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236842 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL A/S NA 5016692

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR METPHORMIN| HUMALOG| ACTOS