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Catalog Number 07P57-20 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/07/2023 |
Event Type
malfunction
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Event Description
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The customer observed falsely elevated alinity c calcium results for one sample.The following data was provided: sid:(b)(6), initial result (b)(6) = 2.57 mmol/l, repeat = 3.51 mmol/l (abnormal curve), repeat on another alinity (b)(6) = 3.72 mmol/l.The customer performed a precision test on sid: (b)(6) for troubleshooting purposes (units of measure = mmol/l): alinity 1 (b)(6): 2.66, 2.74, 2.73, 2.71, 2.71, 2.61, 2.70, 2.74, 2.88, 2.93.Alinity 2 (b)(6): 2.51, 2.5, 2.46, 2.49, 2.52, 2.47, 2.48, 2.51, 2.48, 2.55.The sample was repeated after aliquoting the sample: alinity 1 (b)(6) = 2.34 mmol/l, alinity 2 (b)(6) = 2.31 mmol/l.A comparison study was completed with 30 patient samples and no discrepant results were generated/reported.No impact to patient management was reported.
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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.
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Manufacturer Narrative
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The complaint investigation for falsely elevated alinity c calcium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and 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 search for similar complaints did not identify an increase in complaint activity for lot 02298un23.A review of tracking and trending did not identify any trends for the issue for the product.Device history review did not identify any non-conformances or deviations with lot 02298un23 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity c calcium reagent lot 02298un23 was identified.
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Event Description
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The customer observed falsely elevated alinity c calcium results for one sample.The following data was provided: sid (b)(6) initial result ((b)(6)) = 2.57 mmol/l, repeat = 3.51 mmol/l (abnormal curve), repeat on another alinity ((b)(6)) = 3.72 mmol/l the customer performed a precision test on sid 9006210416 for troubleshooting purposes (units of measure = mmol/l): alinity 1 ((b)(6)): 2.66, 2.74, 2.73, 2.71, 2.71, 2.61, 2.70, 2.74, 2.88, 2.93 alinity 2 ((b)(6)): 2.51, 2.5, 2.46, 2.49, 2.52, 2.47, 2.48, 2.51, 2.48, 2.55 the sample was repeated after aliquoting the sample: alinity 1 ((b)(6)) = 2.34 mmol/l, alinity 2 ((b)(6)) = 2.31 mmol/l.A comparison study was completed with 30 patient samples and no discrepant results were generated/reported.No impact to patient management was reported.
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Search Alerts/Recalls
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