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Catalog Number 03R89-62 |
Device Problem
Computer Software Problem (1112)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Event Description
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On (b)(6) 2023, the customer provided a sample id (b)(6) that was said to have incorrect data populated in the aliniq ams base software regarding a alinity i total b-hcg test result.The following data was provided: 1st result was primary = 964.20 miu/ml; secondary result transmitted from instrument = positive 2nd result after running the automatic dilution, primary result < 7000 miu/ml; secondary result transmitted from instrument = positive however, ams read primary result < 7000 and flag <, for which exists a rule that generates the result as absent.It was noted that the aliniq ams base software was incorrectly configured for the alinity i total b-hcg result.It was noted that the dilution was automatically triggered by the ams due to an incorrect rule configuration.There was no impact to patient management reported.
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Manufacturer Narrative
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The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of ticket trending did not identify any related trends for the current complaint issue.A review of the device history record did not identify any non-conformances or deviations related to the complaint issue.Labeling was reviewed and adequately addresses the issue under review.In this case, the issue was identified as an incorrect configuration of the qpl (quality programming language) rules on the aliniq ams software version 3.01 (ln 03r89-62) for the alinity i total b-hcg assay.Based on the investigation, the aliniq ams software version 3.01 (ln 03r89-62) is performing as intended, no systemic issue or product deficiency was identified.
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Event Description
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On 08dec2023, the customer provided a sample id (b)(6) that was said to have incorrect data populated in the aliniq ams base software regarding a alinity i total b-hcg test result.The following data was provided: 1st result was primary = 964.20 miu/ml; secondary result transmitted from instrument = positive.2nd result after running the automatic dilution, primary result < 7000 miu/ml; secondary result transmitted from instrument = positive.However, ams read primary result < 7000 and flag <, for which exists a rule that generates the result as absent.It was noted that the aliniq ams base software was incorrectly configured for the alinity i total b-hcg result.It was noted that the dilution was automatically triggered by the ams due to an incorrect rule configuration.There was no impact to patient management reported.
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Search Alerts/Recalls
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