On (b)(6) 2022, the lay user/patient contacted lifescan (lfs) canada, alleging that their onetouch verio reflect meter was reading inaccurately high compared to a continuous glucose monitoring device (cgm).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy occurred on the morning of (b)(6) 2022, at 11:00 am.The patient claimed obtaining a reading of ¿3.2 mmol/l¿ with the cgm device then ¿10.2 mmol/l¿ on the subject meter.The patient stated that prior to the alleged issue, they began having a seizure and proceeded to check their glucose with the assistance of a third-party (lay individual).The patient manages their diabetes with long-acting insulin (tresiba) and fast-acting insulin (admelog).When the reading of ¿10.2 mmol/l¿ on the subject meter was obtained, the patient claimed they trusted the meter and took action by administering an increased dose (15 units) of admelog insulin.At around 11:30 am that morning, the patient¿s seizure worsened, and a third-party (lay individual) treated them with glucose gel followed by honey, sugar and dextrose.The patient stated that they re-checked their glucose at 12:00 pm when they felt well, and obtained a reading of ¿5.4 mmol/l¿ with the cgm device compared to a reading which was ¿3 units apart¿ on the subject meter.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca confirmed the test strip vial was intact, the test strips had been stored correctly and the correct testing process was being followed.However, the patient was unable to recall if the test strip vial had been opened for longer than the discard date.The cca noted the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed worsening symptoms suggestive of a serious injury adverse event after administering insulin based on an alleged inaccurate result obtained with the subject meter.
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