Catalog Number 03P68-21 |
Device Problem
Low Test Results (2458)
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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 depressed magnesium results on the architect c8000 analyzer.The following data was provided: initial 6 mg/dl, repeat 1.9.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 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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Manufacturer Narrative
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The suspect medical device lot number was updated on 3jan2019 from unknown to 32990un18.Device evaluated by mfr: an evaluation is still in process.
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Manufacturer Narrative
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On jan 31, 2019, the suspect medical device was updated from ln 03p68-31 lot 32990un18 to ln 03p68-21 lot unknown.An evaluation is still in process.A final report will be submitted when the evaluation is complete.
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Manufacturer Narrative
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Lot number was updated from unknown to 32990un18.An evaluation is still in process.A final report will be submitted when the evaluation is complete.Device evaluated by mfr: an evaluation is still in process.
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Search Alerts/Recalls
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