Catalog Number 04625315003 |
Device Problem
High Test Results (2457)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Occupation is lay user/patient.This event occurred in (b)(6).The complained test strips have been calibrated against the who standard and are in scope of the roche initiated recall.For these test strips there is a potential for a product problem when the inr is > 4.5.Values > 4.5 inr showed an increasing positive bias.The information in the case is consistent with the details of the recall and the issue has been fully investigated.
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Event Description
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The initial reporter questioned high results of 8.0 inr for the past 15 days on coaguchek xs meter serial number (b)(4).The customer had discrepant inr results from his meter compared to an unknown laboratory method.The result from the meter was 8.0 inr.The result from the laboratory within 4 hours was 5.5 inr.Another test was performed on the meter and the result was still 8.0 inr.The customer's therapeutic range is 2.0 - 3.0 inr.The customer was advised to hold his coumadin based on the laboratory result.
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Search Alerts/Recalls
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