It was reported that during the use of the cleo® 90 infusion set, the patient experienced two kinked cannulas.According to the reporter, the patient blood glucose rose to 545 mg/dl due to the reported event.The patient reportedly inserted a new infusion site, administered insulin injects, and delivered a bolus to resolve their high blood glucose.According to the report, the patient was administered to the emergency room on (b)(6) 2016, due to high blood glucose levels and large amount of ketones.It was stated that the patient's ketone levels were life threatening.After the emergency room visit, the patient was admitted to the hospital until (b)(6) 2016.It was reported that the patient had a blood glucose level of 350 mg/dl at the time of admittance to the emergency room.According to the report, the patient was at the emergency room for approximately 2 hours and received intravenous saline therapy and an insulin drip.The patient was reportedly dehydrated and vomiting when discharged from the emergency room.While in the hospital the patient received intravenous saline therapy and an insulin drip.It was reported that the cartridge and infusion set was in patient use for 2 days prior to the reported event; the insulin was in use for less than 28 days.No permanent adverse effects to patient reported.Related mfr#: 3012307300-2017-00307.
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