On (b)(6) 2018, the lay user/ patient contacted lifescan (lfs) usa alleging that her onetouch ultramini meter was reading inaccurately high compared to another, onetouch ultra, meter.The complaint was classified based on customer service representative (csr) documentation and a review of the call recording conducted by the medical surveillance specialist (mss) on (b)(6) 2018.The patient reported obtaining the alleged inaccurately high result of ¿258 mg/dl¿ at around 8am on (b)(6) 2018, with her onetouch ultramini meter compared to the result of ¿134 mg/dl¿ which she obtained with another, onetouch ultra meter, ¿after 9am¿ on the same day.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.In addition, the reported time difference between results of greater than 30 minutes makes this comparison invalid for the purposes of determining an inaccuracy.The patient manages her diabetes with insulin ¿ self adjuster and she reported that, in response to the alleged inaccurately high result, obtained 8:00am, she gave herself ¿4 extra units of insulin¿ at 8:30am.She then reported that at 9am, as a result of these increased doses of insulin, she began to develop ¿hypoglycaemic symptoms and the shakes¿.In response to these symptoms the patient ¿ate carbs¿ as treatment.During troubleshooting, the csr verified that the subject meter¿s unit of measure was set correctly at the time of testing and the results were obtained from an approved sample site.The csr was unable to walk the patient through a control solution test as the patient did not have any control solution.Replacement products, including control solution, were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking an increased dose of insulin based on an alleged inaccurately high result obtained with the subject meter.
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