Lot Number 4863068 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Appropriate Term/Code Not Available (3191)
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Patient Problem
Tachycardia (2095)
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Event Date 09/03/2022 |
Event Type
Injury
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Event Description
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On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs) mexico, alleging that their onetouch ultra meter read inaccurately high compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy first began on (b)(6) 2022, and that on the morning of (b)(6) 2022, they obtained an inaccurate high blood glucose reading of ¿153 mg/dl¿ with the subject meter.The patient manages their diabetes with oral medication (type not specified).The patient claimed they continued to follow their usual diabetes management regimen in response to the alleged issue.The patient reported experiencing ¿tachycardia¿ on the morning of (b)(6) 2022, after obtaining the reading of ¿153 mg/dl¿ with the subject meter.The patient indicated they spoke with their doctor and the symptoms resolved after they self-treated with food.The patient denied their blood glucose was tested with any other device.The patient indicated they had their blood pressure measured during the time of the event and it was ¿ok¿.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.
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Event Description
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On september 06, 2022, the lay-user/patient contacted lifescan (lfs) mexico, alleging that their onetouch ultra meter read inaccurately high compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy first began on (b)(6) 2022, and that on the morning of (b)(6) 2022, they obtained an inaccurate high blood glucose reading of ¿153 mg/dl¿ with the subject meter.The patient manages their diabetes with oral medication (type not specified).The patient claimed they continued to follow their usual diabetes management regimen in response to the alleged issue.The patient reported experiencing ¿tachycardia¿ on the morning of (b)(6) 2022, after obtaining the reading of ¿153 mg/dl¿ with the subject meter.The patient indicated they spoke with their doctor and the symptoms resolved after they self-treated with food.The patient denied their blood glucose was tested with any other device.The patient indicated they had their blood pressure measured during the time of the event and it was ¿ok¿.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.
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Search Alerts/Recalls
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