MAUDE Adverse Event Report: BECKMAN COULTER ACCESS CEA; SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

Model Number	33200
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported erroneous reproducible elevated cea (access cea (carcinoembryonic antigen), part number 33200 and lot number 295069) were generated for one (1) patient on the customer's dxi (unicel dxi 800 access immunoassay analyzer, part number 973100 and serial number (b)(4)) on (b)(6) 2002.On (b)(6) 2022 the customer reported a change to patient treatment or management occurred in conjunction with the incident.The patient underwent a fibroscopy and an endoscopy.There was no further report of change to patient treatment or patient outcome.The original cea patient result was over range (ovr flagged) >994.0 g/l on (b)(6) 2022 (9:31).It was manually diluted and following results were obtained: 5.5 g/l and 5.7 g/l when diluted 1/10 on (b)(6) 2022.On (b)(6) 2002 the patient sample was tested for cea; results of 939.8 g/l and 968.9 g/l were obtained.On (b)(6) 2022, patient sample was tested as follows: 1.4 g/l when diluted 1/2 and 2841.5 g/l when diluted at 1/10.The customer¿s dilution were not linear.The patient sample was also tested for cea using the roche cobas method; results were low at 3.4 ng/ml (<4.7 ng/ml) on (b)(6) 2022 and 3.1 ng/ml on (b)(6) 2022 (second sample).No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.No issues with sample integrity were reported by the customer.The sample was collected on a serum tube, it was clear, the clot time was greater than 30 minutes, it was centrifuged at 2000 g for 10 minutes.The customer agreed to send the patient sample to beckman coulter for investigative testing.
Additional Manufacturer Narrative
The full identifier for this event is (b)(6).The customer did not provide patient demographics such as weight, ethnicity or race.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.No issues with sample integrity were reported by the customer.The sample was collected on a serum tube, it was clear, the clot time was greater than 30 minutes, it was centrifuged at 2000 g for 10 minutes.The customer agreed to send the patient sample to beckman coulter for investigative testing.The patient sample was received and interference testing was performed by the beckman coulter complaint handling unit (chu).Interference testing demonstrated presence of interference related to alkaline phosphatase and was the cause of the erroneous elevated cea results.In conclusion, the cause of the erroneous elevated cea results was the presence of alkaline phosphatase interferent in the patient sample.

• Brand Name: ACCESS CEA
• Common Device Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 14939288
• Report Number: 2122870-2022-00029
• Device Sequence Number: 14996968
• Product Code: DHX
• UDI-Device Identifier: 15099590624842
• UDI-Public: (01)15099590624842(17)230404(11)220401(10)295069
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K031270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 33200
• Device Catalogue Number: 33200
• Device Lot Number: 295069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Female