On june 14, 2022, the lay-user/patient contacted lifescan (lfs), alleging that their onetouch ultra mini meter read inaccurately high compared to another device (emergency medical services meter).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began on (b)(6) 2022.The patient reported obtaining blood glucose readings of ¿121 mg/dl¿ with the subject meter and ¿20 mg/dl¿ on the other device, performed more than 30 minutes apart.The patient manages their diabetes with a once weekly non-insulin injection and oral medications.It was not reported if the patient made any changes to their usual diabetes management regimen as a result of the alleged issue.The patient reported developing symptoms of ¿loss of awareness, started to act funny, loss of memory, shaky and headache¿ on (b)(6) 2022.The patient claimed they were treated by the emergency medical services (ems) with iv glucose and food.The patient claimed their blood glucose measured ¿20 mg/dl¿ on the ems device before treatment.The patient also mentioned that their healthcare professional stopped their medication until further review.At the time of troubleshooting, the cca noted that an approved sample site was used for testing.The cca noted that the patient was testing with test strips that were expired since 2014.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute low blood glucose excursion after the alleged inaccuracy issue occurred.The subject meter could not be ruled out as a cause or contributor to the event.
|