Catalog Number 05964075001 |
Device Problems
Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/02/2024 |
Event Type
malfunction
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Event Description
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We received an allegation of questionable ise results for 2 patients' samples tested on a cobas 8000 cobas ise module when compared to a different cobas 8000 cobas ise module.Results for the sodium (na) test were affected: sample 1 (patient 1): initial result: 131 mmol/l.Repeat result: 139 mmol/l.Sample 2 (patient 2): initial result: 127 mmol/l.Repeat result: 137 mmol/l.Qc was within ranges prior to running the patients' samples.The customer then noticed a moving average error prompting the rerun of the samples.The repeat results were deemed to be correct.
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Manufacturer Narrative
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The na electrode expiration date was not provided.The cobas 8000 cobas ise module serial number was 1982-10.The investigation is ongoing.
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Manufacturer Narrative
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The calibration was last performed on 02-jan-2024 and it was acceptable.The alarm trace showed multiple alarms including calibration errors, noise errors, incubator bath water level sensor alarms, and water reservoir level too-low alarms.The fse found that the sample probe was damaged.He replaced the sample probe and performed sample probe adjustments.The fse then performed ise checks and they were successful.Precision studies were performed and they were within specifications.The customer performed qc and it was within the ranges.The cause was due to a damaged sample probe.The service actions (replacing the sample probe and performing sample probe adjustments) resolved the issue.No further issues were reported afterward.
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Search Alerts/Recalls
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