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

Model Number CA 15-3 G2

Device Problems Mechanical Problem (1384); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

A sample from the patient was submitted for investigation.

Event 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.

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.

Manufacturer Narrative

Medwatch fields b3 and b6 were updated.

• Brand Name: ELECSYS CA 15-3 II
• Type of Device: 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
• MDR Text Key: 311580976
• Report Number: 1823260-2023-00858
• Device Sequence Number: 1
• Product Code: MOI
• UDI-Device Identifier: 04015630939961
• UDI-Public: 04015630939961
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K181492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female