Catalog Number 05964067001 |
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 11/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The c502 module serial number was (b)(6).Calibration and qc were acceptable.The customer had no issues with other patient samples.The customer cleaned the sample probe and performed a sample probe wash.The field service engineer (fse) found an issue with the rinse station leading to water overflow.The fse replaced the rinse tubing.The customer had no further issues after the service visit.The investigation is ongoing.
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Event Description
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The initial reporter complained of a discrepant low result for 1 patient sample tested for cobas integra creatinine plus ver.2 assay (crep2) on a cobas 8000 c 502 module.The initial result was 0.55 mg/dl.The sample was repeated twice with results of 1.22 mg/dl and 1.17 mg/dl.
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Manufacturer Narrative
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Section d, device identification was updated.Relevant fields of sections d and g were updated.The crep2 reagent lot number was 734446 with an expiration date of 31-mar-2024.A reagent issue can be excluded.The investigation determined the issue identified and resolved by the fse (leaky cell rinse tubes) was the cause of the event.The service maintenance actions resolved the issue.
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Search Alerts/Recalls
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