On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultramini meter displayed an inaccurately high result compared to another meter.The complaint was classified based on the customer care advocate (cca) documentation.The patient claimed that the subject meter was reading inaccurately at 12:13am on (b)(6)2018, when she obtained an alleged inaccurately high blood glucose result of ¿156 mg/dl¿ on both the subject meter and another onetouch ultramini meter.The patient manages her diabetes with levemir and humulin r insulin and metformin oral medication.The patient denied making any changes to her usual diabetes management routine after obtaining the alleged inaccurate result.She reported that around 2 hours later, at 2am on (b)(6) 2018, her family were unable to wake her up as she had ¿passed out¿ and been incontinent.She indicated that the family gave her apple juice to treat her symptoms and called the emergency medical services (ems).She reported that when the paramedics arrive at 2:45am, they obtained a blood glucose result of ¿23 mg/dl¿ on the ems meter which she compared to the result on the subject meter from a couple of hours previously.Meter to other meter comparisons do not reasonably suggest that a malfunction has occurred.There can be no presumption as to which meter¿s reading is erroneous as the comparison is not made to a calibrated reference method.The patient reported that she received treatment from the paramedics of ¿iv glucose¿.During troubleshooting, the cca noted that the patient¿s meter was set to the correct unit of measure.The patient confirmed that he had used an approved sample site to obtain the blood samples and she described the correct testing steps.However, the cca also noted that the patient¿s test strips had expired in april 2018, invalidating the results obtained on the onetouch meters.The cca provided education on test strip expiry and replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs and symptoms suggestive of a serious injury adverse event, after obtaining an alleged inaccurately high blood glucose result on the subject meter.
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