Catalog Number 08H67-01 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2023 |
Event Type
malfunction
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Event Description
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The customer observed falsely elevated white blood cell (wbc) results generated from cell dyn ruby analyzer for several patients.The one result example provided which does not match with patient clinical picture.The results were: initial=93 10e3/ul /repeated=90 and 85 10e3/ul.The customer expected to be normal wbc result within normal laboratory reference range for this patient.Laboratory reference range for wbc=5 to 10 10e3/ul there was no reported impact to patient management.
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Manufacturer Narrative
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An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Manufacturer Narrative
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During the requested site visit, the field service engineer (fse) performed troubleshooting procedures and found that accumulated dirt was found in the tubing connected to the flow cell.A review of the tracking and trending report determined that there are no trends for the product for the complaint issue.A review of all complaints associated and a review of complaint trends for the list number was performed.The review did not identify any adverse trends.Additionally, labeling was reviewed and adequately addressed the issue under review.Based on the information provided, the issue was resolved by service.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the ruby analyzer, serial number (b)(6).
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Event Description
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The customer observed falsely elevated white blood cell (wbc) results generated from cell dyn ruby analyzer for several patients.The one result example provided which does not match with patient clinical picture.The results were: initial=93 10e3/ul /repeated=90 and 85 10e3/ul the customer expected to be normal wbc result within normal laboratory reference range for this patient.Laboratory reference range for wbc=5 to 10 10e3/ul there was no reported impact to patient management.
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Search Alerts/Recalls
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