MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 15-3 II; ANTIGEN TUMOR IMMUNOLOGICAL TEST SYSTEM

Model Number	CA 15-3 G2
Medical Device Problem Codes	Mechanical Problem (1384); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample from the patient was submitted for investigation.
Event or Problem Description
There was an allegation of questionable high results for multiple assays for one patient from cobas e 801 analytical unit serial number (b)(4).The results were reported outside of the laboratory and the doctor believed the results did not match the medical imaging results and questioned if there were interfering substances.Refer to the attachment to the medwatch for all patient data.Refer to the medwatches with the following a1 patient identifiers for all involved assays: (b)(6) for the ca 15-3 assay.(b)(6) for the cea assay.(b)(6) for the cyfra 21-1 assay.(b)(6) for the ca19-9 assay.(b)(6) for the ca 125 assay.(b)(6) for the afp assay.
Additional Manufacturer Narrative
The patient sample was investigated and no cause for the result discrepancies could be found.The customer¿s results were confirmed.No product issue was found and the reagent performed within specifications.A general reagent-related issue could be excluded.
Additional Manufacturer Narrative
Medwatch fields b3 and b6 were updated.

• Brand Name: ELECSYS CA 15-3 II
• Common Device Name: ANTIGEN TUMOR IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16566989
• Report Number: 1823260-2023-00858
• Device Sequence Number: 17568729
• Product Code: MOI
• UDI-Device Identifier: 04015630939961
• UDI-Public: 04015630939961
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181492
• 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,Followup
• Report Date (Section B): 04/28/2023

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 Model Number: CA 15-3 G2
• Device Catalogue Number: 07027001190
• Device Lot Number: 606621
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 04/07/2023; 04/27/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 04/10/2023; 04/28/2023
• 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 Age: 74 YR
• Patient Sex: Female