ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I CEA REAGENT KIT; SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
|
Back to Search Results |
|
Catalog Number 07P62-30 |
Device Problem
Low Test Results (2458)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/10/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
|
|
Event Description
|
The customer observed a falsely decreased alinity i cea result for a cancer patient.The following data was provided: sample id 406218372 initial result, on (b)(6) 2023, was <2 ug/l.The patient was redrawn and tested on (b)(6) 2023, and the result was 381 ug/l.The patient was redrawn and tested on (b)(6) 2023, and the result was 321 ug/l.The patient¿s previous result, on (b)(6) 2023, was 193 ug/l.There was no impact to patient management reported.
|
|
Manufacturer Narrative
|
The complaint investigation for a falsely decreased alinity i cea result 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 the complaint lot.Trending review determined no related trend for the product.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review on lot number 42723fn00 did not identify any non-conformances or deviations with the likely cause lot.Accuracy testing was performed using panels, which mimics patient samples, and an in-house retained kit of lot 42723fn00, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i cea, lot number 42723fn00, was identified.
|
|
Event Description
|
The customer observed a falsely decreased alinity i cea result for a cancer patient.The following data was provided: sample id (b)(6) initial result, on 10jul, was <2 ug/l.The patient was redrawn and tested on 24jul2023, and the result was 381 ug/l.The patient was redrawn and tested on 31jul2023, and the result was 321 ug/l.The patient¿s previous result, on 02jul2023, was 193 ug/l.There was no impact to patient management reported.
|
|
Search Alerts/Recalls
|
|
|