Catalog Number 04625315160 |
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 10/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The test strips' expiration date was not provided.The coaguchek xs meter serial number used at the coagulation clinic was not provided.The test strips were requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.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.
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Event Description
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We received an allegation of questionable inr results for 1 patient tested on a coaguchek xs meter compared to another coaguchek xs meter at a different facility (pain management clinic).At 10:25 am the patient was tested in the pain management clinic and received a meter result of 1.0 inr.The patient was then tested in a coagulation clinic in the same building and received a meter result of 1.9 inr.The time difference between the test measurements was within minutes.The physician believed that 1.9 inr was the correct result.The patient¿s therapeutic range was not provided.Reportedly, the result of 1.9 inr was alleged to be outside the patient's therapeutic range.
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Manufacturer Narrative
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Section h6, type of investigation code was updated.
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Search Alerts/Recalls
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