BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® TENDER INFUSION SET

    MDR report key: 3072408 · Received April 23, 2013

    Report

    Report Number
    2183996-2013-00728
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 14, 2013
    Report Date
    May 13, 2013
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED, THE MATERIAL MEETS PRODUCT SPECIFICATIONS. RESULT NO MATERIAL RECEIVED. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND CLICK. 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 EXPERIENCING LEAKING ISSUES. PATIENT STATED HE DISCOVERED THE LEAK BECAUSE HE SMELLED THE INSULIN AND SAW A WET SPOT ON HIS CLOTHING. PATIENT REPORTED HE DOES HEAR THE AUDIBLE CLICK WHEN ATTACHING THE INFUSION SET TUBING TO THE INFUSION SITE. PATIENT STATED HE IS NOT SURE WHERE THE LEAK ORIGINATED BECAUSE THE CANNULA IS NOT BENT OR KINKED. PATIENT REPORTED THE INFUSION DEVICE WAS IN USE WHEN THE LEAK OCCURRED. PATIENT STATED HE HAS HAD THIS ISSUE ABOUT 4 OR 5 TIMES WITH THIS PAST SHIPMENT OF SUPPLIES. PATIENT DISCARDED THE ALLEGED INFUSION SET. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. 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
    175351 ACCU-CHEK ® TENDER INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL A/S NA 214145

    Patients

    Seq Age Sex Outcome Treatment
    1 027 YR INSULIN (TYPE NOT PROVIDED)