Catalog Number 03666794001 |
Device Problem
Circuit Failure (1089)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2021 |
Event Type
malfunction
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Event Description
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It was reported that a patient had power issues with coaguchek xs meter (b)(4) and batteries within the meter burned the battery covering.An error indicating an error applying blood to a test strip also occurred on the meter.The meter batteries were replaced several times due to the meter losing power.Batteries were replaced using new (b)(6) batteries.The meter would not turn on.When removing older batteries, the user's finger was burned.The user did not require medical attention.Smoke may have been seen coming from inside the battery area and there was a slight burning smell from the battery.The user did not need to evacuate due to alleged smoke.The battery cover was burnt on one side.
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Manufacturer Narrative
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The customer's meter was requested for investigation and replacement product was sent to the customer.Initial reporter occupation - the occupation is patient/consumer.
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Manufacturer Narrative
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The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.
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Search Alerts/Recalls
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