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

Catalog Number	11776193122
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 - cobas e 602 module is (b)(6).The patient sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys ca 19-9 results from six samples from the same patient tested on the cobas 8000 - cobas e 602 module.The reporter stated that the patient has been regularly tested for the assay over the past 3 years on the analyzer.The results were always high but no tumor was found during the examinations.The patient's sample was recently tested in a different institution that uses a beckman coulter dxi 800; the result was within the normal range.On (b)(6) 2021, the result from the module was >1000 u/ml.On (b)(6) 2022, the result from the module was >1000 u/ml.On (b)(6) 2023, the result from the module was 723.20 u/ml.On (b)(6) 2023, the result from the module was 781.7 u/ml.On (b)(6) 2024, the result from the module was 540.9 u/ml.On (b)(6) 2024, the result from the module was 457.5 u/ml.The repeat result from another e602 module was 478.7 ku/l.On (b)(6) 2024, the result from the beckman coulter dxi 800 analyzer was 13 u/ml (<35).
Additional Manufacturer Narrative
The customer stated that the qc was within the +/-1 standard deviation range on (b)(6) 2024.The investigation excluded a general reagent issue.The patient sample was not provided for investigation.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS CA 19-9
• Common Device Name: TEST, CARBOHYDRATE ANTIGEN (CA19-9)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18697630
• Report Number: 1823260-2024-00423
• Device Sequence Number: 7126811
• Product Code: NIG
• UDI-Device Identifier: 04015630904297
• UDI-Public: 04015630904297
• Combination Product (Y/N): Y
• Initial Reporter Country: HU
• PMA/510(K) Number: K050231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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 Catalogue Number: 11776193122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Female