Information was received that the cadd cleo infusion sets did not deliver the insulin.The cannula of the catheter was reportedly kinked during pricking.Patient experienced very high blood sugar at 566 mg, high proportions of ketones, shortness of breath and other physical complications.Patient was able to reduce their blood sugar without external/medical help because they had an insulin pen they used.Customer has since been using a different lot and reportedly no longer experiences this event.
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Other, other text: device evaluation- three used samples were returned for evaluation.The devices were inspected and no discrepancies were found.The devices were given functional testing; the devices were found to allow fluid through with no leakage detected.The reported issue was not confirmed during testing of samples.During production, this device type is sampled at regular intervals to ensure needle is properly threaded on the retractor assemblies.In addition, the devices are sampled for occlusion testing.
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