Catalog Number 03P68-31 |
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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All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
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Event Description
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The customer observed falsely elevated magnesium results on the architect c16000 analyzer.The following data was provided: sid (b)(6) initial 1.87, repeat 0.7, 0.7 mmol/l.There was no impact to patient management reported.
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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.No return patient sample was available.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within expected 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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Manufacturer Narrative
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D4) on aug 22, 2019, the lot number (72256un19 ) was provided and was updated from unknown in the suspect medical device section.An evaluation is still in process.A follow up will be submitted when the evaluation is complete.
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Search Alerts/Recalls
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