Catalog Number 08D06-74 |
Device Problem
False Negative Result (1225)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/11/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
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, architect )b)(6) tp, list 8d06-74, that has a similar product distributed in the us, list number 8d06-31/-41.Complete entry = (b)(6).No further information was provided.
|
|
Event Description
|
The customer obtained a false (b)(6) tp result for a (b)(6) female with a history of (b)(6) infection.Sample id (b)(6) generated a (b)(6) s/co on the architect and negative on rpr.The sample generated positive results on roche 4.54 s/co, autobio 10.16 s/co, colloidal gold rapid test strip and tppa.While troubleshooting the issue the customer also sent the sample to another hospital which tested the sample on an abbott platform and generated a non-reactive results of 0.98 s/co.No impact to patient management was reported.
|
|
Manufacturer Narrative
|
H6 health effect impact code: f26.H6 component code: g01003.D8 was this device serviced by a third party? no.The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and testing of a retained kit of the complaint lot number.Return testing was not completed as returns were not available.Review of complaint activity and trending reports did not identify any issues or trends related to the complaint issue.Device history record review for the lot did not identify any non-conformances or deviations.A retained kit of the complaint lot was tested in a sensitivity setup.All specifications were met and no false non-reactive results were obtained, indicating that the sensitivity performance is acceptable.Based on our investigation, no systemic issue or deficiency of the architect syphilis tp reagent lot was identified.D4 expiration date was changed from 1/21/2021 to 1/20/2021 due to a typo.D10 was changed from yes to no since the device was not available.
|
|
Manufacturer Narrative
|
This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.
|
|
Search Alerts/Recalls
|