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

Model Number CA 15-3 G2

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

Hold for at 2.8 the initial reporter stated they received unexpected results for samples from two patients tested with the elecsys ca 15-3 ii assay on a cobas 8000 e 801 module.The sample results were reported outside of the laboratory to a physician who complained the values were unexpectedly high for these asymptomatic patients.A first sample from the first patient resulted with a ca 15-3 value of 36.5 ku/l on (b)(6) 2020.A second sample from the first patient resulted with a ca 15-3 value of 37.3 ku/l on (b)(6) 2021.A first sample from the second patient resulted with a ca 15-3 value of 38.0 ku/l on (b)(6) 2021.A second sample from the second patient resulted with a ca 15-3 value of 39.1 ku/l on (b)(6) 2021.A positron emission tomography scan of the patient performed on this date did not show abnormalities.The serial number of the e 801 analyzer is (b)(4).Ca 15-3 reagent lot number 470054 was in use from (b)(6) 2020.Ca 15-3 reagent lot number 501545 was in use starting on (b)(6) 2020.

Manufacturer Narrative

Calibration data from (b)(6) 2020 was ok.Quality controls were within range.No patient material was available for investigation.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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
• MDR Report Key: 11292272
• MDR Text Key: 250323925
• Report Number: 1823260-2021-00369
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• PMA/PMN Number: K181492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• 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: 470054, 501545
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOLVADEX (PATIENT 2)