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

Catalog Number 03045838122

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable high ca 15-3 results for two patient samples where various scans on the patients were negative.Of the data provided, only one patient was tested with the elecsys ca 15-3 ii assay.The patient had breast cancer in 2010 treated by surgery, radiotherapy, and hormone therapy and was monitored for ca 15-3 using the kryptor-brahms method.On (b)(6) 2015, the ca 15-3 result was 30.9 ku /l.The breast mri was normal and the patient was well.On (b)(6) 2015, the ca 15-3 result was 32.8 ku /l.In (b)(6) 2015, the patient had a tep that was a normal scan.On (b)(6) 2016, the ca 15-3 result was 97.8 ku /l, which triggered a new pet scan that showed nothing.In (b)(6) 2017, the patient had a bone scintigraphy with nothing to report.On (b)(6) 2017, the ca 15-3 result was 260.5 ku /l.As the ca 15-3 results increased but many imaging tests were negative, the customer suspected interference.Dilutions of the samples were performed and did not change the results.On (b)(6) 2017, two of the samples were repeated using the elecsys ca 15-3 ii assay and a cobas 6000 e 601 module.The serial number of the analyzer was requested, but it was not provided.The sample from (b)(6) 2017 had a result of 300.0 ku/l with a data flag and 280.1 ku/l with a 1:10 dilution.The sample from (b)(6) 2016 had a result of 113.4 ku/l and 111.2 ku/l with a 1:10 dilution.Testing using an hbt tube was negative.The presence of rheumatoid factors (igm and iga) was found to be negative.All of the results were reported outside the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

Samples from the patient were submitted for investigation.No interference could be detected in the samples.The results obtained by the customer were considered to be correct and no general reagent issue was suspected.

• 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: 6622157
• MDR Text Key: 77420875
• Report Number: 1823260-2017-01178
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• 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: 192171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• 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