BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
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Model Number AU481-10E CHEMISTRY ANALYZER AU480 WITH ISE |
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 02/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The customer performed their own troubleshooting with the support of beckman field service engineer and evaluated the analyzer.The customer re-seated the electrodes, cleaned the blocks, and replaced ise tubing to resolve the issue.The customer performed calibration and quality control, which all passed.The customer verified the analyzer resumed to normal operation.Section a2, a4, and a5: information not provided by customer.Beckman coulter internal identifier is case(b)(4).
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Event Description
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The customer reported two patients had low sodium (na) and chloride (cl) results on their au480 clinical chemistry analyzer.The customer repeated the patient samples and obtained normal results.The customer released the correct results out of the laboratory.There was no report of change to treatment, injury, or death associated with this event.The customer did not provide patient demographics.The customer provided the results for two patients.
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