Catalog Number 07D70-21 |
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 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.
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Event Description
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The customer observed a falsely elevated magnesium result on the architect c8000 analyzer.The following data was provided: sid (b)(6) initial 6.0, repeat 1.6 mg/dl.There was no impact to patient management reported.
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Manufacturer Narrative
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The lot number 45338un17 was provided on (b)(6) 2017.An evaluation is still in process, and a follow up report will be provided when the evaluation is complete.
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Manufacturer Narrative
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Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the customer's issue.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within established control limits.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
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Search Alerts/Recalls
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