On october 25, 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that the patient¿s onetouch ultra 2 meter was reading inaccurately high.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.A follow up call was made with the patient by customer care (cc), however the patient was not willing to provide more information about the event.The patient claimed that the alleged issue began approximately 3 or 4 months ago, around (b)(6) 2021, at an unspecified time.The patient stated that they received unspecified inaccurate high readings with the subject meter.The patient manages their diabetes with insulin (self-adjuster) and reported that they increased the dose of insulin in response to the high readings.At an unspecified time after the alleged issue occurred, the patient went into a ¿diabetic coma¿.The patient informed the cca that they went to the hospital where they received unspecified treatment.During troubleshooting, the cca walked the patient through a retest and the control solution was in range with a reading of ¿135 mg/dl¿ on the subject meter.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 after taking an increased dose of insulin based on alleged inaccurate high results obtained with the subject meter.There is insufficient information to rule out the contribution of the subject meter to the event.
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