On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs), alleging that their onetouch ultra2 meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy occurred on (b)(6) 2022.The patient claimed obtaining blood glucose readings of ¿479 to 488 mg/dl¿ with the subject meter, performed within 20 minutes each other.The patient stated they manage their diabetes with humalog mix 75/25 insulin and administered an increased dose of insulin (20 units instead of 7 units) in response to the alleged issue.90 minutes after the insulin was administered, the patient started to develop symptoms of ¿arms shaking and slower speech¿.As a result of the symptoms, the patient claimed they went to the hospital where their blood glucose measured ¿39 mg/dl¿ on the hospital meter.It was not specified what treatment the patient received.The patient indicated they were hospitalized for 3 days.During troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter and the same approved sample site was used for testing.The cca confirmed the test strip vial was intact and the test strips had been stored correctly and were not expired or opened past their discard date.The cca noted that the patient did not have control solution available to perform a quality control test.The patient declined to have the products replaced.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after administering an increased dose of insulin based on alleged inaccurate results obtained with the subject meter.
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