On (b)(6) 2021, the patient called lifescan (lfs) us alleging that they were getting error 2 and error 4 messages on their onetouch verio flex meter.The complaint was classified based on the customer care agent (cca) documentation.The patient stated that the alleged issue had been ongoing ¿since the beginning of (b)(6)¿.A test performed during the call resulted in an error 4 message being displayed.The patient reported that they had experienced ¿memory loss, headache, light-headedness and dizziness¿ ¿since the beginning of (b)(6)¿.They manage their diabetes with a combination of insulin and oral medication however, no further details regarding type(s) or dosage(s) were provided.The only action taken by the patient in response to the error 2 and error 4 messages was to call lfs for assistance.They did not receive any treatment for their symptoms nor did they report making any changes to their normal diabetes management.During troubleshooting, the cca determined that the storage and testing technique were correct and the patient confirmed that this was not the first time the product was used.A replacement device was sent to the patient.This complaint is being reported because the patient claims they were unable to test their blood glucose due to the reported issue and reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged issue began.The subject device could not be ruled out as a contributing factor.
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