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

Model Number CA 15-3 G2

Device Problem High Test Results (2457)

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

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

Calibration signals were slightly lower than expected.Qc results fluctuated.No further information was provided by the customer.Due to the limited information provided, the cause of the event could not be determined.Product labeling states: "the measured ca 15 3 value of a patient's sample can vary depending on the testing procedure used.The laboratory finding must therefore always contain a statement on the ca 15 3 assay method used.Ca 15 3 values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.If there is a change in the ca 15 3 assay procedure used while monitoring therapy, then the ca 15 3 values obtained upon changing over to the new procedure must be confirmed by parallel measurements with both methods." the investigation did not identify a product problem.

Event Description

The initial reporter complained of high results for 3 patient samples tested for elecsys ca 15-3 ii (ca 15-3 ii) on a cobas e 411 immunoassay analyzer.Patient 1 had an initial result of 27.74 u/ml from the e411 analyzer.The sample was repeated twice with results of 28.17 u/ml and 27.48 u/ml.The customer alleged these results were higher than the results from other laboratories.The results from the other laboratories were not provided.Patient 2 initial result was 36 u/ml from the e411 analyzer.The patient went to the hospital where the result from an unknown method was 14 (unit of measure not provided).The patient went to another laboratory where the result from an unknown method was 22 (unit of measure not provided).Patient 3 initial result was 31.55 u/ml from the e411 analyzer the result from a different laboratory using an unknown method was 22.0 u/ml.The results from the e411 analyzer were reported outside of the laboratory.The e411 analyzer serial number was (b)(4).

• Brand Name: ELECSYS CA 15-3 II
• Type of Device: TUMOR-ASSOCIATED ANTIGEN 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: 16416122
• MDR Text Key: 309954320
• Report Number: 1823260-2023-00528
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K010588
• 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
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: CA 15-3 G2
• Device Catalogue Number: 03045838122
• Device Lot Number: 60656904
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• 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