On (b)(6) 2023, the patient/lay user contacted lifescan (lfs) brazil by email alleging that his onetouch ultra mini meter read inaccurately low compared to a laboratory test.The complaint was classified based on the patient¿s email and on information obtained from the customer care agent (cca) during a follow up call with the patient.The patient reported that the alleged issue began on (b)(6) 2023, at 07:00 am.The patient claimed obtaining a blood glucose reading of ¿108 mg/dl¿ with the subject meter.The patient manages his diabetes with diet and exercise and claimed that at an unspecified time after he received the reading on the subject meter, he started feeling ¿dizziness and nausea¿ and went to the hospital.The patient reported that he ¿fainted¿ at the hospital.That same day at 09:00 am, the doctor performed a laboratory test and obtained a reading of ¿405 mg/dl¿.The patient stated that after the laboratory test, he was treated with an unspecified serum at the hospital.During troubleshooting, the cca confirmed that the patient had used an approved sample site to obtain the blood sample.The cca educated the patient on the use of control solution.The patient was unable to provide test strip details because he discarded the vial and test strips.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event and received hcp treatment for an acute high blood glucose excursion after using the product and the subject meter could not be ruled out as a cause or contributor to the event.
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