On (b)(6) 2021, the reporter of the lay user/patient contacted lifescan (lfs) usa alleging that his wife¿s onetouch ultra 2 meter displayed inaccurately high results compared to a laboratory device.The complaint was classified based on the customer care agent (cca) documentation.The reporter alleged that the issue first started on (b)(6) 2021, at an unspecified time.The reporter¿s wife obtained blood glucose readings of ¿400 and 330 mg/dl¿ on the subject meter and compared this to a reading of ¿129 mg/dl¿ on a laboratory device, taken less than 30 minutes apart from each other.The reporter claimed that his wife did not take any food or medication between the readings.The patient manages her diabetes with humalog insulin (self-adjuster) and the reporter stated that she increased her dose of insulin to 80 units in response to the alleged issue.At an unspecified time after the issue occurred on the same day, the patient developed symptoms of ¿dizziness, shakiness, sweatiness and loss of some senses¿.The reporter denied that the patient received any medical treatment but claimed that his wife only tested to verify her blood glucose levels.During troubleshooting, the cca confirmed that the patient had used an approved sample site to obtain the blood samples.The cca noted that the patient did not have control solution at the time of the call to test the subject system.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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