On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs), alleging that their onetouch verioflex meter read inaccurately high compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began at an unspecified time on (b)(6) 2022.The patient reported obtaining an alleged inaccurate high blood glucose reading of ¿285 mg/dl¿ with the subject meter.The patient manages their diabetes with a fixed dose of insulin (humulin r and humulin n).The patient reported administering their usual dose of insulin in response to the elevated reading then almost immediately (exact time not reported) developed symptoms of feeling ¿shaky, breathless and sweaty¿; symptoms they associated with a low blood glucose.The patient claimed they treatment themselves with orange juice in response to the symptoms.The patient denied that their blood glucose was tested with any other device.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter and the correct testing process was being followed.The cca confirmed the test strip vial was intact and the test strips had been stored correct and were not expired or opened past their discard date.The cca noted the patient did not have control solution available to perform a quality control test.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 while using the product.The alleged meter issue could not be ruled out as a cause or contributor to the event.
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