On (b)(6) 2022, the lay user/patient contacted lifescan (lfs) usa, alleging his onetouch verio reflect meter was reading erratically high.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on additional information obtained after the medical surveillance specialist (mss) reviewed the call recording.The patient stated that the alleged inaccuracy issue began approximately a month prior to the call with lfs, at an unspecified time.The patient claimed that since he bought the subject meter, he obtained inaccurate high blood glucose readings of ¿277, 242, 246, 250 and 313 mg/dl¿ on the subject meter.The patient manages his diabetes with a combination of insulin and pills (levemir 43 units, novolog 12 units and metformin pills).The patient reported that on (b)(6) 2022 at 6:50 am he received a reading of ¿250 mg/dl¿ and immediately after increased both of his insulins by 10 units.The patient stated that consequently he ¿started to feel dizzy, blanked out and fell down¿.The patient indicated that his wife helped him however, he denied receiving any medical treatment for the reported symptoms.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 after taking increased doses of insulin based on alleged inaccurate high results obtained with the subject meter.
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