Catalog Number 03L77-01 |
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.(b)(4).
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Event Description
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The customer states that as time passes, control values and precision checks begin failing for the clin chem magnesium assay run on an architect c16000 analyzer in their lab.They have also had to retest patient samples and send out corrected reports.One example given was for sample (b)(6), which generated an initial result of 0.70 mmo/l and retested at 0.50 mmol/l (the customer stated that this patient was known to generated low magnesium results).A service call was initiated.There have been no reports of any impact to patient care due to this issue.
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Manufacturer Narrative
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An abbott field service engineer (fse) visited the customer site and replaced the sample syringe seal tips and cuvette washer dry tips.The r2 reagent probe was also calibrated.Subsequent instrument operations and test results were acceptable.A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.The architect system operations manual contains information to address the current customer issue.Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred.The issue was addressed through standard troubleshooting procedures.
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Manufacturer Narrative
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The device evaluation was reassessed and concluded that a malfunction occurred; therefore, the device was not performing as intended and section.
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Search Alerts/Recalls
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