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Model Number 08P1934 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/02/2022 |
Event Type
malfunction
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Event Description
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The customer stated falsely decreased magnesium results were generated on the alinity c analyzer for three patients.The customer was made aware of the issue when the physician questioned the low magnesium results.The following data was provided: normal patient range is 1.6 to 2.6 mg/dl.Patient 4 initial result = 1.24 mg/dl, repeat result = 1.66 mg/dl.Patient 6 initial result = 1.18 mg/dl, repeat result = 1.63 mg/dl.Patient 7 initial result = 1.25 mg/dl, repeat result = 1.70 mg/dl no impact to patient.Management was reported.
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Manufacturer Narrative
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Patient identifier: patient 4, patient 6, patient 7.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 decreased magnesium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, field data review and labeling 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.Ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances, potential non-conformances or deviations with lot 36462ud00 and complaint issue.The historical performance of the magnesium reagent was reviewed using field data from customers worldwide.The median patient result for lot 36462ud00 is within the established baseline, indicating the reagent lot is comparable with other lots in the field, confirming no systemic issue for the lot.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the magnesium reagent for lot 36462ud00 was identified.
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Search Alerts/Recalls
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