Catalog Number 08D06-32 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Code Available (3191)
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Event Date 02/19/2020 |
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.This report is being filed on an international product, list number 8d06-32 that has a similar product distributed in the us, list number 8d06-31.All patient information provided has been included in this report.
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Event Description
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The customer observed a false reactive architect syphilis tp result when processing on the architect i1000sr.The following data was provided for the (b)(6) year old female patient: sid3001182902.Generated initial result of 10.4s/co (>/=1.00s/co =reactive) on 19feb2020; rpr=negative.Due to the false reactive syphilis results and for neurological reasons a cerebrospinal sample (csf) was taken and sent to a reference lab.The csf and the serum tested negative with vitro's rpr, tpa, and tpa chemiluminescence ocd.The customer then retested the original sample (sid18829 on 24feb2020) on architect = 12.64s/co / rpr =negative.This sample was sent to the reference lab where it tested negative.Patient was evaluated at a day clinic for cognitive deficit.Tests included imaging and blood.Imaging report indicated moderately to severely decreased perfusion parietotemporal (re> li) and more limited hippocampal (re> li).Mesial temporal atrophy (mta) grade 2.Also determination of biological markers on lumbar fluid for the diagnosis of alzheimer's.The results of this are indicative of underlying amyloid pathology.
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Manufacturer Narrative
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A review of tickets determined normal complaint activity for lot 10028be00 and no trends were identified for the product for the issue.Return testing was not completed as returns were not available.Specificity testing was performed with a retained kit of lot 10028be00 and a specificity panel.Results of this setup did not implicate that the performance regarding specificity of the lot is negatively impacted.No false reactive results were obtained.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect syphilis tp reagent, lot 10028be00.
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Manufacturer Narrative
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Corrected information for section d2 product code from incorrect mtn to correct lip.
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Search Alerts/Recalls
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