MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT CEA REAGENT KIT; SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

Model Number	07K68-27
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased architect cea results on one (b)(6) female patient diagnosed with colon cancer.The results provided were: on (b)(6) initial= 3.8 ng/ml /repeated 1:2 dilution=< 5.0 ng/ml /on (b)(6)=3.9 ng/ml /on (b)(6) result=53.3 ng/ml /previous history for cea=around 3.0 ng/ml additional information provided: ca19-9 xr=3.2 the customer questioning the cea results=53.3 ng/ml on 08sep.There was no reported impact to patient management.
Additional Manufacturer Narrative
Patient information: no specific patient information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, field data of architect cea reagent lot 26467fn00.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of complaints determined that there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Historical performance of reagent lot 26467fn00 was evaluated using worldwide data from abbottlink.The median value of the negative patient population for the complaint lot is within the established limits and comparable to historical reagent lot performance.All field data demonstrating that the lot is performing as expected.Per labeling review, specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (hama).Such specimens may show either falsely elevated or depressed values when tested with assay kits such as architect cea that employ mouse monoclonal antibodies.Additional information may be required for diagnosis.Architect cea reagents contain a component that reduces the effect of hama reactive specimens.Additional clinical or diagnostic information may be required to determine patient status.Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference, and anomalous values may be observed.Additional information may be required for diagnosis.Per the limitations of the procedure section of the product package insert, a serum or plasma cea level, regardless of value, should not be interpreted as absolute evidence for the presence or absence of malignant disease.The cea level should be used in conjunction with information available from clinical evaluation and other diagnostic procedures.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 cea reagent lot 26467fn00.

• Brand Name: ARCHITECT CEA REAGENT KIT
• Common Device Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12844939
• Report Number: 3008344661-2021-00205
• Device Sequence Number: 15351920
• Product Code: DHX
• UDI-Device Identifier: 00380740014575
• UDI-Public: 00380740014575
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/16/2021

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: 10/20/2022
• Device Model Number: 07K68-27
• Device Catalogue Number: 07K68-27
• Device Lot Number: 26467FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2K PROC MOD, 03M74-01, ISR52139; ARC I2K PROC MOD, 03M74-01, ISR52139
• Patient Age: 84 YR
• Patient Sex: Female