BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® INSIGHT TENDERLINK PLUS INFUSION SET

    MDR report key: 16303832 · Received February 6, 2023

    Report

    Report Number
    3011393376-2023-00327
    Event Type
    Injury
    Date Received
    February 6, 2023
    Date of Event
    January 31, 2023
    Report Date
    July 22, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. THE USED MATERIAL WAS DISCARDED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ERRORS THAT OCCURRED IN THE SUBMISSION OF MDRS FOR INCORRECT MANUFACTURER NAME AND/OR ADDRESS. A NON-CONFORMANCE REPORT (NCR) ¿ 16847 TO IMPLEMENT CORRECTIVE ACTIONS WAS OPENED ON JANUARY 29, 2025. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER OF THE INFUSION SET WAS A ADMITTED TO HOSPITAL DURING THE NIGHT ON (B)(6) 2023 DUE TO KETOACIDOSIS AND KETONE BODIES. ON MONDAY (B)(6) 2023, THE PATIENT HAD CHANGED CANNULA, TUBING AND CARTRIDGE. AFTERWARDS SHE WAS SUFFERING FROM HYPERGLYCEMIA. DESPITE ADMINISTERING THREE TIMES 10 INSULIN UNITS VIA THE DIABELOOP DBLG1 BY THE PUMP, HER BLOOD GLUCOSE LEVEL KEPT RISING. NO LEAKAGE, NO OCCLUSION, NO WET ADHESIVE PLASTER WAS DETECTED. NO ERROR MESSAGES WERE TRIGGERED BY THE PUMP EITHER. AT AROUND 12:00 PM, THE PATIENT CALLED THE AMBULANCE, BUT WHEN THE PATIENT OPENED THE DOOR, THE PARAMEDICS STATED THE PATIENT IS IN TOO GOOD STATE FOR AN INFUSION AND LEFT AGAIN. AT 02:00 PM THE PATIENT DROVE TO THE INTENSIVE CARE UNIT OF THE HOSPITAL. THERE SHE WAS TREATED WITH INSULIN INFUSION AND THE PUMP, CANNULA AND TUBING WERE DISCONNECTED. THE PATIENT STATED THE PUMP WAS DELIVERING CORRECTLY, BUT SOMETHING HAPPENED WITH THE INFUSION SIDE. THE HEALTH CARE PROFESSIONAL SUSPECTED THE INSULIN DISAPPEARED IN THE FATTY TISSUE. THE CANNULA WAS LAST SET ON (B)(6) 2023 AT THE ABDOMINAL SKIN FOLD, THE ADHESIVE PLASTER WAS NOT WET. THE PATIENT WILL FOLLOW UP WITH THE HEALTH CARE PROFESSIONAL ABOUT CANNULA TYPE AND INSERTION SIDES. SHE WAS PROVIDED WITH A PEN AND IF ISSUE OCCURS AGAIN, THE PATIENT WILL USING PEN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108345 ACCU-CHEK ® INSIGHT TENDERLINK PLUS INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. 1382978

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention| H NOVORAPID INSULIN.