On august 26, 2022, the reporter of the lay user/patient contacted lifescan (lfs) usa, alleging that the patient¿s onetouch verio flex meter was reading inaccurately high compared to his feelings and/or normal readings.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The reporter alleged that the product issue began on (b)(6) 2022 at 5 pm.The reporter claimed that the patient obtained a blood glucose reading of ¿587 mg/dl¿ on the subject meter.The patient manages his diabetes with an unspecified insulin (self-adjusting dose, twice a day) and the reporter stated that the patient increased his insulin intake with an unspecified dose at 5:10 pm in response to the high readings.The reporter informed the cca that at 7 pm that same day, the patient started to develop symptoms of ¿confusion, nausea, can¿t get up and sweating¿.The reporter claimed that the patient was treated with glucose tablets/glucose gel, provided by another person at 7:10 pm.At 7:00 pm, before treatment, a blood glucose reading of ¿41 mg/dl¿ was obtained on another unspecified meter.The reporter indicated that the patient felt better a few minutes after treatment.During troubleshooting, the cca noted that the subject meter was set to the correct unit of measure.The cca confirmed that the patient¿s test strips had been stored correctly, were within expiry date and the test strip vial was not cracked or broken.The patient did not have control solution available to test the subject meter.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking an increased dose of insulin based on an alleged inaccurate high result obtained with the subject meter.
|