MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CA 19-9 ELECSYS E2G; CARBOHYDRATE ANTIGEN (CA19-9) TEST SYSTEM

Model Number CA 19-9 ELECSYS E2G

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Medwatch field expiration date: april 2022.Medwatch field udi number: (b)(4).

Event Description

The initial reporter stated they received questionable results for one patient sample tested with the elecsys ca 19-9 immunoassay on two cobas 8000 e 801 module analyzers.The results did not agree with the clinical condition of the patient.The patient sample was tested twice on the customer's e 801 analyzer, resulting in ca 19-9 values of < 2.0 u/ml and < 2.0 u/ml (reference range = < 37 u/ml).These results were reported outside of the laboratory to the physician.The sample was repeated on an abbott architect analyzer, resulting in a ca 19-9 value of 775 u/ml (reference range = < 37 u/ml).The sample was also provided for investigation, where it was tested on a second e 801 analyzer, resulting in a ca 19-9 value of 2.600 u/ml.The serial number of the customer's e 801 analyzer was requested, but not provided.Ca 19-9 reagent lot 504743, with an expiration date of april 2022 was used on this analyzer.The serial number of the e 801 analyzer used for investigation is (b)(4).Ca 19-9 reagent lot 504743, with an expiration date of april 2022 was used on this analyzer.

Manufacturer Narrative

During investigations, the sample was treated with protein a and repeated on the e801 used for investigation and the architect analyzer.The e801 result after treatment was 2.72 u/ml (105 % recovery).The architect result after treatment was 12.5 u/ml (2 % recovery).

Manufacturer Narrative

Calibration and controls were acceptable on the e 801 analyzer used for investigation.The investigation determined that discrepant results were obtained due to an erroneously high result measured on the abbot architect.The roche ca19-9 results were assessed to be correct.The investigation did not identify a product problem.

• Brand Name: CA 19-9 ELECSYS E2G
• Type of Device: CARBOHYDRATE ANTIGEN (CA19-9) TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11768369
• MDR Text Key: 250243244
• Report Number: 1823260-2021-01328
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• PMA/PMN Number: K050231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA 19-9 ELECSYS E2G
• Device Catalogue Number: 07027028190
• Device Lot Number: 504743
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1