On august 25, 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra 2 meter displayed inaccurately erratic blood glucose results.The complaint was classified based on the customer care agent (cca) documentation.The patient alleged that the product issue began at 5:00 am on (b)(6) 2021.The patient reported that he obtained blood glucose readings of ¿62 and 233 mg/dl¿ on the subject meter, within 20 minutes from each other.The patient manages his diabetes with insulin (levemir - 11 units and lantus ¿ 20 units) and stated that he ate something sweet after he received the first low reading of ¿62 mg/dl¿.The patient claimed that he developed symptoms at 5:05 am of ¿dizziness, sweaty¿ and his ¿stomach hurts¿.He also mentioned that he ¿felt sleepy¿.The patient indicated that because he felt sick, he tested again with the subject meter and received the high reading of ¿233 mg/dl¿.The patient treated himself with 20 units of lantus insulin.He stated that he felt better an hour later.No other blood glucose readings from other devices have been reported.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 established that the test strips had been stored properly, were not open beyond their discard date and had not expired.However, the patient informed the cca that the test strip vial was broken or cracked, but there was no indication of misuse to the product.The cca walked through a control solution test and concluded that the result was in range.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 something sweet based on alleged inaccurate low result obtained with the subject meter.
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