On (b)(6) 2021, the patient/lay user contacted lifescan (lfs) usa alleging that his onetouch verio iq meter read inaccurately high compared to his feelings and/or normal results.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged issue began on (b)(6) 2021, in the evening.The patient claimed obtaining a blood glucose reading of ¿80 mg/dl¿ with the subject meter and indicated that after the reading he ¿had a faint, could not move¿ and had to call for help.Within 30 minutes the paramedics arrived and they obtained a blood glucose reading of ¿43 mg/dl¿ on an emergency medical services (ems) meter.The patient manages his diabetes with diet and exercise and claimed that he did not make any changes to his usual diabetes management regimen in response to the alleged issue.The patient informed the cca that he was treated by an hcp with a glucose injection.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter, the patient had used an approved sample site to obtain the blood samples and that the patient was following the correct testing procedure.The cca noted that the patient did not have control solution at the time of the call to test the subject system.The cca established that the test strip vial was intact, that the test strips had been stored properly, were not open beyond their discard date and had not expired.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 and because the patient reportedly received hcp treatment for an acute low blood glucose excursion after the alleged product issue began.The subject meter could not be ruled out as a cause or contributor to the event.
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