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

Catalog Number	11776193122
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 - cobas e 602 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable ca 19-9 elecsys results from the cobas 8000 - cobas e 602 module that were questioned by the clinicians.On (b)(6) 2023, sample 1 initial result was >1000 ku/l and the result on (b)(6) 2023 with a 1:10 dilution was 400.3 ku/l.On (b)(6) 2023, sample 2 initial result was >1000 ku/l and the result with a 1:10 dilution was 196.6 ku/l.Sample 3 initial result was >1000 ku/l and the result with dilution was 465.0 ku/l.Sample 4 initial result was >1000 ku/l and the result with a 1:10 dilution was 103.0 ku/l.
Additional Manufacturer Narrative
Medwatch field d4 expiration date was updated.The investigation did not identify a product problem.The cause of the event could not be determined.A general reagent problem was not present, because the qc prior to the event was within ranges.

• 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: 18596608
• Report Number: 1823260-2024-00248
• Device Sequence Number: 8024905
• Product Code: NIG
• UDI-Device Identifier: 04015630904297
• UDI-Public: 04015630904297
• Combination Product (Y/N): Y
• Initial Reporter Country: SF
• 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): 03/20/2024

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 Expiration Date: 09/30/2024
• Device Catalogue Number: 11776193122
• Device Lot Number: 70569100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 57 YR
• Patient Sex: Female