MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 125 II; TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)

Catalog Number	11776223161
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e601 module serial number was: (b)(4).
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for elecsys ca 125 ii (ca 125 ii) on a cobas 6000 e601 module.The initial result was 5.41 u/ml.This result was rejected by the physician.A new sample was obtained, and the result was 507.6 u/ml.This result was believed to be correct.The original sample was repeated with a result of 487.8 u/ml.
Additional Manufacturer Narrative
Qc was acceptable.No maintenance issues were identified.The field service engineer (fse) did not identify any instrument issues.The fse performed a 21-cup precision and qc with results within specification.A patient sample was run with no issues.The customer used a centrifugation time of 8 minutes with a speed of 4000 revolutions per minute (rpm).Based on the sample tubes used, this time may be too short and the speed too fast.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS CA 125 II
• Common Device Name: TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23621615
• Report Number: 1823260-2025-04791
• Device Sequence Number: 9072314
• Product Code: LTK
• UDI-Device Identifier: 04015630945795
• UDI-Public: 04015630945795
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: 05/31/2026
• Device Catalogue Number: 11776223161
• Device Lot Number: 847601
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/23/2026
• 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 Sex: Unknown