The customer reported a false elevated alinity c calcium result for a patient when running on the alinity c processing module.The following data was provided (customer¿s normal range: 8.5 ¿ 10.5 mg/dl): on (b)(6) 2021 = initial calcium result = 16.2 mg/dl, repeated on another alinity analyzer = 9.8, 9.5 mg/dl.There was no impact to patient management reported.
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The complaint investigation for false elevated alinity c calcium results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A ticket search by lot 81839un21 did not identify an increase in complaint activity for the current issue.Trending was reviewed and did not identify any trends for the product for the issue.The device history record was reviewed, and no non-conformances or deviations were identified.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for alinity c calcium, reagent lot 81839un21 was identified.
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