Model Number 98100EU |
Device Problem
Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation conclusion: the customer's complaint was not replicated during in-house testing of retained devices of lot number t13190rn.Devicesof the complaint lot performed properly when tested with a positive calibrator, no issues with d-dimer recovery were observed.Lot performed within specification.Manufacturing batch records for lot t13190rn were reviewed and found that the lot met final release specifications.Based on the information available, there is no indication of a product deficiency and no correction action is required.
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Event Description
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Customer had discrepant low results with d-dimer tests when compared to the lab results on the same sample.Customer stated that there was a delay in treatment due to these results.The patient was symptomatic prior to testing.No other information provided.
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Manufacturer Narrative
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The final diagnosis was negative for dvt or pe.Clinical outcome matched triage result.
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Event Description
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The final diagnosis was negative for dvt or pe.Clinical outcome matched triage result.
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Search Alerts/Recalls
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