Catalog Number 04625374160 |
Device Problems
Device Difficult to Setup or Prepare (1487); Incorrect, Inadequate or Imprecise Result or Readings (1535); Lack of Maintenance Documentation or Guidelines (2971)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter occupation is patient/consumer.The meter test strips were requested for investigation.The meter was returned for investigation.The investigation is ongoing.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.Customer received an error 5.The error 5 was caused by not enough blood being applied to the test strip to complete the test.
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Event Description
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The customer complained of discrepant inr results with coaguchek xs meter serial number (b)(6).At 11:11 am, the repeat meter result was 2.9 inr.The customer repeated the test and the result was 5.7 inr.Customer's therapeutic range is 2.5-3.5 inr.The customer tests every two weeks.
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Manufacturer Narrative
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The returned meter was measured with the retention test strips 64708110 in comparison to the current test strip master lot.For this purpose two human blood samples from marcumar donors and internal reference meters were used.Donor 1 hct: 43%, donor 2 hct: 40%.Testing results: donor #1: retention meter and master lot strips: 4.0 inr, returned meter and retention strips: 3.7 inr.Donor #2: retention meter and master lot strips: 3.0 inr, returned meter and retention strips: 2.8 inr.All inr values were within the specified target ranges, confirming the functionality of the coaguchek measuring system.No error messages occurred.Returned customer material and retention material complies with specification.
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Search Alerts/Recalls
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