Catalog Number 06P02-60 |
Device Problem
False Positive Result (1227)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/28/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
|
|
Event Description
|
The customer reported false reactive alinity s hbsag assay on cadaveric sample and provided the following information: reference = 1.0 s/co is reactive on (b)(6) 2023, sample id (b)(6) initial result was 16.99 (reactive) and repeat results were 16.99 (reactive) & 15.64 (reactive).Nat result was negative.Tissue status: retained, mother tested negative on (b)(6) 2023 patient information: 3 day old male who was found unresponsive at home.Information regarding medications: 4 doses of epinephrine.Hepatitis b vaccination occurred on (b)(6) 2023.There was no reported impact to patient management.
|
|
Manufacturer Narrative
|
Section h3 was updated to state that device evaluation is still in processsection d4 lot# was corrected h3 other text : device evaluation is still in process.
|
|
Event Description
|
The customer reported false reactive alinity s hbsag assay on cadaveric sample and provided the following information: reference = 1.0 s/co is reactive.On (b)(6) 2023, sample id (b)(6) initial result was 16.99 (reactive) and repeat results were 16.99 (reactive) & 15.64 (reactive).Nat result was negative.Tissue status: retained, mother tested negative on (b)(6) 2023.Patient information: 3 day old male who was found unresponsive at home.Information regarding medications: 4 doses of epinephrine.Hepatitis b vaccination occurred on (b)(6) 2023.There was no reported impact to patient management.
|
|
Manufacturer Narrative
|
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review did not identify any potential non-conformances, non-conformances, or deviations with the complaint lot.Ticket search by lot did not identify an increase in complaint activity for the complaint issue.The ticket trending review did not identify any trends.The overall performance of the alinity s hbsag reagent was reviewed using field data from customers.A review of field data for the overall performance of lot 50489fn00 indicated the product was performing within product requirements.Labeling was reviewed and was found to address the customer reported issue.Based on the results of the investigation, alinity s hbsag reagent, lot number 50489fn00 met performance requirements and no systemic issue or product deficiency was identified.
|
|
Event Description
|
The customer reported false reactive alinity s hbsag assay on cadaveric sample and provided the following information: reference = 1.0 s/co is reactive on (b)(6) 2023, sample id (b)(6) initial result was 16.99 (reactive) and repeat results were 16.99 (reactive) & 15.64 (reactive).Nat result was negative.Tissue status: retained, mother tested negative on (b)(6) 2023 patient information: 3 day old male who was found unresponsive at home.Information regarding medications: 4 doses of epinephrine.Hepatitis b vaccination occurred on (b)(6) 2023.There was no reported impact to patient management.
|
|
Search Alerts/Recalls
|