Catalog Number 07762798003 |
Device Problems
Low Test Results (2458); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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Event Description
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There was an allegation of questionable results from the coaguchek inrange meter.The result from the meter was 2.3 inr.One hour later, the clinic's result using a coaguchek meter was 3.5 inr.The therapeutic range was 3.0-3.5 inr and the patient usually tests every second day.
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Manufacturer Narrative
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The coaguchek inrange 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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Manufacturer Narrative
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The returned meter and strips were provided for investigation where they were tested using a high-level control sample.Testing results (qc range = 2.4 ¿ 3.6 inr): qc 1: 2.9 inr.Qc 2: 2.9 inr.Qc 3: 2.9 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Medwatch fields d4 and d9 were updated.
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Search Alerts/Recalls
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