Catalog Number 04625374160 |
Device Problems
No Device Output (1435); High Test Results (2457); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The meter serial number was (b)(6).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.E3 - occupation was patient/consumer.
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Event Description
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There was an allegation of questionable results from the coaguchek xs meter.At 8:19 pm, the result was 6.1 inr.At 8:21 pm and using a different finger, the result was 4.4 inr.The patient had taken a cough syrup for a few days due to a bad cough.The therapeutic range was 2.5 inr-3.5 inr and the patient tests once a week.
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Manufacturer Narrative
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No product was received for investigation.The investigation did not identify a product problem.
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Manufacturer Narrative
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The customer's meter was provided for investigation and was tested using retention strips and retention controls.Level 1 testing results (qc range = 1.0 - 1.4 inr): qc 1: 1.2 inr.Level 2 testing results (qc range = 2.3 - 3.5 inr): qc 2: 2.9 inr.The obtained qc values were in the allowed range; all measurements were without error messages.The results alleged by the customer were observed in the meter¿s result memory.The investigation did not identify a product problem.
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Search Alerts/Recalls
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