Model Number 07P5730 |
Device Problem
High Test Results (2457)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/03/2020 |
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.Patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.
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Event Description
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The customer observed falsely elevated calcium results for several patients on an alinity c analyzer.The following data was provided (customer's normal range is 8.5-10.5 mg/dl): sample id (b)(6) initial result, on (b)(6) 2020, was 15.3, repeat was 8.1 mg/dl.Sample id (b)(6) initial result, on (b)(6) 2020, was 14.1, repeat was 9.1 mg/dl.Sample id (b)(6) initial result, on (b)(6) 2020, was 14.7, repeat was 9.8 mg/dl.Sample id (b)(6) initial result, on (b)(6) 2020, was 14.4, repeat was 6.5 mg/dl.Sample id (b)(6) initial result, on (b)(6) 2020, was 16.0, repeat was 7.8 mg/dl.There was no impact to patient management reported.
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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 provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.A review of tickets determined that there is normal complaint activity for alinity c calcium reagent ln 7p57-30/lot number 37978un19.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.Review of the capa database found no issue related to the current complaint.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics' complaint investigation, no systemic issue or deficiency of alinity c calcium reagent ln 7p57-30/lot number 37978un19 was identified.An initial report was submitted under manufacturer report number 3016438761-2020-00210 with abbott laboratories (irving ia/cc) 1915 hurd drive irving, tx 75038 as the manufacturing site, however, that is the incorrect manufacturing site.The correct manufacturing site is weisbaden, germany, which is this report.
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Manufacturer Narrative
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The correct manufacturing site for suspect medical device calcium is abbott laboratories (irving ia/cc) 1915 hurd drive irving, tx 75038 and was submitted under manufacturer report number 3016438761-2020-00210.All further information will be documented under mdr number 3016438761-2020-00210.
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Manufacturer Narrative
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Additional patient data provided by customer on 03jul2020 was added to section b5.
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Event Description
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The customer observed falsely elevated calcium results for several patients on an alinity c analyzer.The following data was provided (customer's normal range is 8.5-10.5 mg/dl): sample id (b)(6) initial result, on (b)(6) 2020, was 15.3, repeat was 8.1 mg/dl sample id (b)(6) initial result, on (b)(6) 2020, was 14.1, repeat was 9.1 mg/dl sample id (b)(6) initial result, on (b)(6) 2020, was 14.7, repeat was 9.8 mg/dl sample id (b)(6) initial result, on (b)(6) 2020, was 14.4, repeat was 6.5 mg/dl sample id (b)(6) initial result, on (b)(6) 2020, was 16.0, repeat was 7.8 mg/dl on 03jul2020, the customer provided additional patient data: sample id (b)(6) initial result, on (b)(6) 2020, was 14.9, repeat was 8.9 mg/dl.There was no impact to patient management reported.
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Search Alerts/Recalls
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