BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDERLINK

    MDR report key: 3181261 · Received June 21, 2013

    Report

    Report Number
    2183996-2013-01133
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 9, 2013
    Report Date
    September 11, 2013
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO PRODUCT REQUESTED TO BE RETURNED.

    Additional Manufacturer Narrative · 1

    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. NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT WAS USING AN INFUSION SITE ON HER ARM. HER BLOOD GLUCOSE LEVEL BECOME ELEVATED AND CHANGED THE SITE TO HER ABDOMEN. THE PATIENT ATTEMPTED TO BOLUS, BUT HER BLOOD GLUCOSE LEVEL CONTINUED TO RISE. SHE WENT TO THE HOSPITAL AND HER BLOOD GLUCOSE LEVEL WAS AROUND 600 MG/DL AND SHE HAD MILD KETOSIS. THE INFUSION DEVICE WAS CHECKED AND FUNCTIONS AS INTENDED. THE PATIENT'S DOCTOR THINKS, THAT DUE TO THE PATIENT BEING OBESE, THE INSULIN ENTERS THE BODY BUT IS TRAPPED IN THE ADIPOSE TISSUE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282277 ACCU-CHEK TENDERLINK INSULIN INFUSION SET FPA UNOMEDICAL A/S 00700006954 227633

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR Hospitalization