MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT CEA; CARCINOEMBRYONIC ANTIGEN

Catalog Number	07K68-32
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information.Patient identifier: complete number (b)(6).Section no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a false negative architect cea result for 1 patient.The following patient data was provided: sid (b)(6) initial result = <0.5 ng/ml, repeat = 327.55 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Review of complaint activity determined that there was normal complaint activity for reagent lot 94415fn00.Review of tracking and trending reports did not identify any related trends for the architect cea assay.Return testing was not completed as returns were not available.Therefore, testing of a serum based panel was performed using a retained kit of lot 94415fn00.All specifications were met indicating the lot is performing acceptably.Using worldwide field data the historical performance of reagent lot 94415fn00 was evaluated.This evaluation indicated that the patient median result for the lot was comparable with all other lots in the field.Therefore, no unusual reagent lot performance was identified for lot 94415fn00.Manufacturing documentation for the lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on this investigation, no systemic issue or deficiency of the architect cea assay was identified.

• Brand Name: ARCHITECT CEA
• Common Device Name: CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8675582
• Report Number: 3008344661-2019-00072
• Device Sequence Number: 16662885
• Product Code: DHX
• UDI-Device Identifier: 00380740014582
• UDI-Public: 00380740014582
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K990774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2020
• Device Catalogue Number: 07K68-32
• Device Lot Number: 94415FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I2000SR, SERIAL (B)(4); ARCHITECT I2000SR, SERIAL (B)(4); LIST 3M74-02; LIST 3M74-02