OT Select Simple Meter

Description of Event or Problem

On (b)(6) 2026, the lay user/patient contacted LifeScan (LFS) India, alleging that his OneTouch Select Simple meter read inaccurately high compared to his feelings and/or normal readings. The complaint was classified based on the Customer Care Agent (CCA) documentation.The patient reported that 4 months ago (exact date not specified), at around 6:00 pm, he obtained what he felt was a high reading with the subject meter (exact result not provided). The patient manages his diabetes with a combination of oral medication (Glyciphage, 1 dose morning and evening) and insulin (normally 4 units before meals). In response to the elevated reading, the patient claimed he took an increased dose of 6 units of insulin then felt ¿weakness¿ and ¿fell down¿ and became ¿unconscious¿. The patient reported that he was immediately taken to the hospital where he was admitted. The patient reported that several tests were performed; however, he was unable to recall the results or the treatment received, as he had been unconscious at the time. At the time of troubleshooting, the CCA determined that the unit of measure was set correctly on the subject meter. Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after administering an increased dose of insulin based on an alleged inaccurate high result obtained with the subject meter. The subject meter could not be ruled out as a cause or contributor to the event.

Additional Manufacturer Narrative

Similar complaints for this issue were trended including the reported meter. It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.