BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® TENDER INFUSION SET

    MDR report key: 2980908 · Received February 27, 2013

    Report

    Report Number
    2183996-2013-00257
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 25, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR CLICK, FLOW, AND LEAKS. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED THE INFUSION SET LEAKED INSULIN AND THIS CAUSED HER BLOOD GLUCOSE TO ELEVATE TO 280 MG/DL. SHE CHECKED HER INFUSION SITE AND FELT WETNESS WHERE THE CANNULA MEETS THE CONNECTOR. SHE CHANGED THE HEADSET IMMEDIATELY, AND THE ALLEGED INFUSION SET WAS DISCARDED. THE INFUSION SITE WAS LOCATED IN HER STOMACH, AND SHE PRACTICES SITE ROTATION. SHE DID HEAR AN AUDIBLE CLICK WHEN THE HEADSET WAS CONNECTED TO THE TUBE. SHE REPORTED THIS HAS OCCURRED WITH 10 INFUSION SETS FROM THE SAME BOX. THE INFUSION SETS WERE REPLACED. SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83635 ACCU-CHEK ® TENDER INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL A/S NA 214140

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR HUMALOG| DEXCOM CONTINUOUS BLOOD GLUCOSE MONITOR