It was reported that during patient use of the cleo® 90 infusion set, the cannula detached from the infusion site and the cannula remained partially inserted in the patient's body.The patient stated that she believed that the waistband of their pants may have sheared the infusion site from the patient's body.The patient reported that they were able to remove the device cannula without issue.According to the reporter, the patient's blood glucose level rose to approximately 300 mg/dl at the time of the event; the patient did not test their ketone levels.The patient administered an insulin injection via a syringe to resolve their high blood glucose.Additionally, the patient reported that they replaced their infusion site and resumed insulin delivery from the infusion pump.No issues were observed when the device was initially opened and the patient stated that they received iv dressings to aid in securing future infusion sites.No permanent adverse effects to patient reported.
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