Catalog Number K3057 |
Device Problem
Incorrect Or Inadequate Test Results (2456)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/22/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Analysis of the instrument and instrument data indicate that the cause for the falsely depressed mg results is unknown.However, the instrument data shows the cluster of depressed mg results was restricted to a reagent well pair in the mg flex reagent cartridge.The issue is under investigation by (b)(4).
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Event Description
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Discrepant depressed magnesium (mg) results were obtained on patient samples.Patient results were reported to physicians.The account repeated the samples on an alternate dimension vista instrument and higher results were obtained.Corrected results were reported.Patient treatment was altered or prescribed for one patient on the basis of the falsely depressed mg result.No information on the type of treatment was provided.There was no report of adverse health consequences as a result of the falsely depressed mg results or the patient's treatment.
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Manufacturer Narrative
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Siemens healthcare diagnostics has received customer complaints for the dimension vista magnesium (mg) lot 15063ba.The complaints were related to erroneous low results on a small number of reagent wells.Siemens healthcare diagnostics issued an urgent medical device recall communication vc-15-12.A.Us dated september 2015 instructing customers to discontinue use and discard any remaining inventory of the affected lot and to contact siemens healthcare diagnostics for replacement product.Data collected from the customer complaints shows that there is the potential for under-recovery on certain wells for quality control(qc) and patient sample results.When this issue occurred, the under-recovery ranged from -0.3 mg/dl [0.12 mmol/l] to - 1.6 mg/dl [0.66 mmol/l].The average under-recovery was -1.0 mg/dl [0.41 mmol/l].This issue is demonstrating a low frequency of occurrence with an estimate one (1) in every 10,000 tests may be affected.Repeating the sample on a new well or a new flex cartridge resolves the issue.This issue is likely to be detected by quality control (qc) or calibrators if they are run on the affected wells of reagent.
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Search Alerts/Recalls
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