Catalog Number 05168589190 |
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 09/27/2023 |
Event Type
malfunction
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Event Description
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There was an allegation of a questionable creatinine (crep gen.2) result from the cobas 8000 c702 module.The initial result was 9.7 mg/dl and was reported outside of the laboratory.The patient had a new sample drawn at another facility and the result did not match.No specific data was provided.The original sample was repeated and the result was 0.6 mg/dl.This result was believed correct.
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Manufacturer Narrative
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The analyzer serial number was (b)(6).The investigation is ongoing.
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Manufacturer Narrative
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The analyzer alarm trace contained multiple sample short and abnormal aspiration alarms on the date of the event near the time the sample was processed.The field service engineer found a film in the water tank.He performed a full decontamination and ran precision testing.The customer ran qc and all results met system specifications.Operational and/or mechanical checks passed.The investigation determined the service actions resolved the issue.
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Search Alerts/Recalls
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