On (b)(6) 2024, the lay user/patient¿s daughter contacted lifescan (lfs) united states, alleging that the patient¿s onetouch ultra2 meter read inaccurately high compared to another meter.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained by the medical surveillance specialist (mss) after reviewing the call recording.During the call, the reporter stated that the patient started to obtain high readings with the subject meter on (b)(6) 2024.The reporter claimed that on the morning of (b)(6) 2024, at 8:26 am, she found the patient ¿acting like a child and incoherent¿ and the patient received a result of ¿260 mg/dl¿ with the subject meter.The reporter called the emergency medical services (ems) for assistance.Whilst ems were in attendance, the reporter claimed the patient received a result of ¿299 mg/dl¿ with the subject meter compared to ¿52 mg/dl¿ on the ems meter, performed 40 mins apart.The reporter claimed the patient started coming around after being given something by ems and was taken to the hospital by ambulance and was admitted.The reporter claimed the patient was treated with orange juice, ginger ale, crackers and blood pressure medication.The reporter did not recall the patient being treated with iv therapy or injections.The patient was discharged at 12:30 pm that same day with a blood glucose level of ¿125 mg/dl¿.During the call, the reporter claimed that prior to the onset of the patient¿s symptoms, the patient had last tested her blood glucose with the subject meter the night before at 9:57 pm and received a result of ¿439 mg/dl¿ and had taken her usual dose of novolin 70/30 insulin (15 units).At the time of troubleshooting, the cca walked the reporter through a control solution test and the result fell outside the specified control solution range printed on the test strip vial.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly experienced an acute low blood glucose excursion requiring hospitalization after the alleged product issue began.The subject meter could not be ruled out as a cause or contributor to the event.
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