BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID-DLINK INFUSION SET

    MDR report key: 2943242 · Received January 21, 2013

    Report

    Report Number
    2183996-2013-00036
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 10, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DESCRIBING A LEAK ON THE LUER CONNECTION CANNOT BE VERIFIED; THE MATERIAL MEETS PRODUCT SPECIFICATIONS. SEVEN RETURNED TRANSFER SETS WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. ADDITIONALLY, THE DIMENSIONAL ACCURACY OF THE LUER WAS TESTED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. FOUR RECEIVED UNUSED CARTRIDGES WERE VISUALLY, LEAK, AND GLIDE FORCE TESTED. THE CARTRIDGES PASSED THE VISUAL AND LEAKAGE TESTS AT DIFFERENT POSITIONS OF THE PLUNGER ROD. THE GLIDE FORCE MEASURED IS IN ACCORDANCE WITH PRODUCT SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED; THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE INITIATED.

    Additional Manufacturer Narrative · 1

    THIS 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.

    Description of Event or Problem · 1

    PATIENT REPORTED HE WAS NOT RECEIVING ANY INSULIN FROM THE INFUSION DEVICE ON (B)(6) 2013. PATIENT STATED HE SAW THE INSULIN WAS LEAKING OUT OF THE INFUSION DEVICE AND NOT GOING INTO THE INFUSION SET TUBING. PATIENT REPORTED THE INSULIN WAS COMING OUT AND SOME WAS ALSO IN THE CARTRIDGE COMPARTMENT. PATIENT STATED HE NOTICED HE WAS NOT RECEIVING ANY INSULIN AFTER A FEW HOURS BECAUSE HE FELT DIFFERENT, AND HIS MOUNT FELT DRY. PATIENT REPORTED HE REPLACED ALL ACCESSORIES AND BEGAN RECEIVING INSULIN AGAIN. PATIENT STATED EVERYTHING WAS WORKING AS IT SHOULD. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28825 ACCU-CHEK RAPID-DLINK INFUSION SET FPA ROCHE HEALTH SOLUTIONS, INC. 00700006933 320233

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR INSULIN INFUSION PUMP| ACCESSORIES| INSULIN