Catalog Number 04625315160 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The meter and strips have been requested for return.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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There was an allegation of questionable results from coaguchek xs meter serial number (b)(6).At 10:40 am, the result from a meter at a clinic was 2.4 inr.At 10:40 am, the results from the coaguchek meter were 2.0 inr and 1.9 inr.The therapeutic range was 2.0-3.0 inr and the customer tests once per week.
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Manufacturer Narrative
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Medical device problem code and type of investigation codes were updated.
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Search Alerts/Recalls
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