On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio flex meter read inaccurately erratic compared to her feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained after customer care (cc) reviewed the initial call with the patient.The patient reported that the alleged meter inaccuracy began approximately 15 days prior the call to lfs around (b)(6) 2021, at an unspecified time.The patient reported that since that time she obtained alleged inaccurate high blood glucose readings of ¿290 and 230 mg/dl¿ at fasting, ¿300 and 290 mg/dl¿ at dinner time and ¿420 and 320 mg/dl¿ before bedtime.The patient manages her diabetes with insulin (humalog ¿ 50 units and "basaglore" ¿ 45 units) and indicated that during those 15 days she stopped eating carbs and took insulin based on the meter results.At an unspecified time after the alleged issue occurred the patient started to feel ¿shaky¿.The patient claimed that she treated herself with her usual dosage of insulin (humalog ¿ 50 units and "basaglore" ¿ 45 units).The patient denied using any other device to test her blood glucose.Follow up with cc confirmed that the patient also felt ¿dizzy¿ and that she started experiencing the symptoms after she treated herself with more insulin.No other medical treatment was reported.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter and the patient had used an approved sample site to obtain the blood samples.A control solution and test strips have been sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after reducing her carb intake and taking insulin based on alleged inaccurate results obtained with the subject meter.
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