Model Number 023-271 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Fatigue (1849); Paresis (1998); Shaking/Tremors (2515)
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Event Date 12/28/2021 |
Event Type
Injury
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Event Description
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On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch verio flex meter was reading inaccurately high compared to another meter.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on information obtained after the cca reviewed the call recording.The patient alleged that the issue began at an unspecified time in the night on (b)(6) 2021, when he obtained a blood glucose result of ¿144 mg/dl¿ on the subject meter.The patient manages his diabetes with unspecified insulin (self-adjuster) and stated that he took 12 units of insulin in response to the reading of ¿144 mg/dl¿.When the patient woke up the next day early in the morning, he felt that his glucose was too low and started developing symptoms of ¿shaking, could not move and felt weak¿.The patient¿s wife helped him obtaining a blood glucose result on a ¿contour next¿ meter and the patient received a reading of ¿39 mg/dl¿.The patient¿s wife gave him some candies and called 911.The patient claimed that he went to the emergency room and received unspecified hcp treatment.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.The cca noted that the patient did not have control solution at the time of the call to test the subject system.A replacement meter has been 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.
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Event Description
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On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch verio flex meter was reading inaccurately high compared to another meter.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on information obtained after the cca reviewed the call recording.The patient alleged that the issue began at an unspecified time in the night on (b)(6) 2021, when he obtained a blood glucose result of ¿144 mg/dl¿ on the subject meter.The patient manages his diabetes with unspecified insulin (self-adjuster) and stated that he took 12 units of insulin in response to the reading of ¿144 mg/dl¿.When the patient woke up the next day early in the morning, he felt that his glucose was too low and started developing symptoms of ¿shaking, could not move and felt weak¿.The patient¿s wife helped him obtaining a blood glucose result on a ¿contour next¿ meter and the patient received a reading of ¿39 mg/dl¿.The patient¿s wife gave him some candies and called 911.The patient claimed that he went to the emergency room and received unspecified hcp treatment.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.The cca noted that the patient did not have control solution at the time of the call to test the subject system.A replacement meter has been 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.
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Search Alerts/Recalls
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