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

Catalog Number 03045838122

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable elecsys ca 15-3 ii assay results for several samples for one patient when compared to the results from an architect analyzer.Information about the analyzer used was requested but was not provided.The result of 25.0 from (b)(6) 2017 was reported to the physician.It was unknown which results were correct for the patient.The patient was not adversely affected.The customer performed dilutions to rule out a hook effect: initial result: 30.37 ui/ml.Diluted at 5:15 (manual): 82.65 ui/ml.Diluted at 1:10 (instrument): 106.4 ui/ml.Possible reasons for difference in the results include the use of different ca15-3 antibodies in the different assays, the different antibodies could recognize different parts of the molecule, antigen heterogeneity, the lack of an international standard for ca15-3, and the different assay formats.

Manufacturer Narrative

Samples from the patient were submitted for investigation and were tested by a third party method.The results from the abbott ca 15-3 assay were confirmed.

Manufacturer Narrative

As part of the investigation, the samples were tested on a cobas 6000 e 601 module and the results were verified.A specific root cause could not be identified.There was no evidence of an interfering substance or hama interference.Product labeling for the assay documents different results can be found for ca 15-3 when using different methods.

• Brand Name: ELECSYS CA 15-3 II ASSAY
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6403544
• MDR Text Key: 69954031
• Report Number: 1823260-2017-00555
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K010588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03045838122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MORPHINE; MOUTHWASH WITH BICARBONATE