Model Number 3L80-21 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/16/2020 |
Event Type
malfunction
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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.There was no additional patient information provided.
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Event Description
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The customer observed falsely decreased co2 results on the architect c4000 analyzer for two pregnant patients.On (b)(6) 2020 sid (b)(6) result 14 meq/l.On (b)(6) 2020 sid (b)(6) result 15 meq/l.The customer's normal range is 22 - 32 meq/l.Values less than 16 meq/l are considered critical.Both patients had normal arterial blood gas co2 values (21 - 23 meq/l).No adverse impact to patient management was reported.
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Manufacturer Narrative
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A review of tickets determined that there is normal complaint activity for lot 56332uq12.Trending review determined no adverse trend for falsely depressed results for the product.Return testing was not completed as returns were not available.The issue appears to be sample specific for certain patient samples.Qc results were within range during the time of this occurrence.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of carbon dioxide (co2) reagent (ln 3l80-22) lot 56332uq12 was identified.
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Search Alerts/Recalls
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