On (b)(6) 2022, the reporter (the son) of the lay user/patient contacted lifescan (lfs) usa, alleging that his mother¿s onetouch ultra 2 meter was reading inaccurately high compared to a calibrated lab method.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 8 pm.The reporter claimed that the patient obtained a blood glucose reading of ¿194 mg/dl¿ on the subject meter.The patient manages her diabetes with novolog insulin (3 units, self-adjusting dose) and the reporter informed the cca that his mother increased her insulin intake by 8 units in response to the high reading.The reporter stated that after his mother took the extra insulin she went to rest and when the son checked on her, she ¿was hot, sweaty and unresponsive¿.The son called 911 and the emergency medical services (ems) tested the patient¿s blood glucose and received a reading of ¿43 mg/dl¿ on an unspecified lab device.The reporter claimed that the reading was taken between 10 and 30 minutes after the alleged inaccurate reading obtained at 8 pm and he denied that the patient had taken any food or medication in between readings.The patient was treated by an hcp with iv glucose in the emergency room (er) after they received the reading of ¿43 mg/dl¿ on a lab device.During troubleshooting, the cca confirmed that the patient had used an approved sample site to obtain the blood samples.The cca educated the reporter on the use of control solution.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 alleged inaccurate high results obtained with the subject meter.
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