Catalog Number 04625374160 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2024 |
Event Type
malfunction
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Event Description
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We received an allegation of questionable inr results with coaguchek xs meter serial number (b)(6).At 1:11 pm, the meter result was 3.7 inr.At 1:21 pm, the meter result was 2.6 inr.Customer's therapeutic range is 2.0-3.0 inr.The customer tests on a weekly basis.
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Manufacturer Narrative
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The meter and test strips were requested for return.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.The investigation did not identify a product problem.The cause of the event could not be determined.
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Search Alerts/Recalls
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