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

Catalog Number	11776223161
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The last calibration performed on (b)(6) 2024 and was successful with no alarms, but the second calibrator level signal was lower than the previous history.The customer re-calibrated after the event occurred and the second level calibrator signal matched previous history.Quality controls were within range before and after the event.The field service engineer determined the issue was related to the shift in calibrator signals and was resolved after the customer re-calibrated the assay.The investigation determined the customer's action of recalibration resolved the issue.
Additional Manufacturer Narrative
The serial number of the e411 analyzer is (b)(6).The field service engineer proactively replaced the measuring cell and tubing.Preventive maintenance was performed on the analyzer.The photomultiplier tube and blank cell calibrations were performed.Performance testing passed.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with the elecsys ca 125 ii assay on a cobas e411 rack.The initial values were reported outside of the laboratory and questioned by a physician as they were higher than expected.The samples were repeated and these values were deemed correct.The first sample initially resulted in a ca 125 value of 974.9 u/ml and it repeated as 676.2 u/ml.The second sample initially resulted in a ca 125 value of 22259 u/ml and it repeated as 12714 u/ml.

• Brand Name: ELECSYS CA 125 II ASSAY
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20305700
• Report Number: 1823260-2024-02778
• Device Sequence Number: 15350530
• Product Code: LTK
• UDI-Device Identifier: 04015630945795
• UDI-Public: 04015630945795
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 10/07/2024

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: 06/30/2025
• Device Catalogue Number: 11776223161
• Device Lot Number: 77413301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/07/2024
• 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: 66 YR
• Patient Sex: Female