Catalog Number 05168589190 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/11/2023 |
Event Type
malfunction
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Event Description
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There was an allegation of questionable crep2 creatinine plus ver.2 results for 2 patient samples on a cobas 8000 c702 module.For sample 1, the initial creatinine result was 5.1 mg/dl.The repeat result was 1.3 mg/dl.For sample 2, the initial creatinine result was 4.2 mg/dl.The repeat result was 0.8 mg/dl.
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Manufacturer Narrative
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The analyzer serial number is (b)(6).The investigation is ongoing.
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Manufacturer Narrative
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Section d product information has been updated, as well as g1 manufacturing site and g4.The customer stated verbally that their qc recovery data was acceptable.The field service engineer (fse) replaced reagent probes, decontaminated the flow path, and performed a precision test and mechanical checks successfully.The customer performed qc successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.
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Search Alerts/Recalls
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