MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 19-9 IMMUNOASSAY TEST, CARBOHYDRATE ANTIGEN (CA19-9)

Catalog Number 11776193122

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for two samples from the same patient tested for the elecsys ca 19-9 immunoassay (ca19-9) on an e601 analyzer. When compared to a result from the siemens method, it was stated that the siemens result better fits with the medical history of the patient. All e601 analyzer results were forwarded to a physician and these results were questioned. The first sample tested on the e601 analyzer resulted as 3. 7 u/ml (reference range is < 34 u/ml). A second sample from the patient was tested after (b)(6) 2016, but before (b)(6) 2016, resulting as approximately 200 u/ml using the siemens method. It was stated that the reference range for the siemens ca19-9 method is similar to that of the roche ca19-9 method. A third sample from the patient was tested on the e601 analyzer on (b)(6) 2016, resulting as 30. 5 u/ml (reference range is < 34 u/ml). The patient was not adversely affected. The e601 analyzer serial number is (b)(4). The customer was informed that the ca19-9 result as determined by assays from different manufacturers can vary due to differences in methodology. The customer questions the specificity and sensitivity of the roche assay.

Manufacturer Narrative

A sample from the patient was provided for investigation. Investigations confirmed that the sample recovered below the reference range of the ca19-9 assay. The sample did not show any evidence for a false low result due to high dose hook effect or specific interferences. Based on investigation measurements, the results obtained by the customer are regarded to be true ca19-9 results. The lower measurements obtained by the customer may be caused by instability of the antigen due to transport or storage conditions. It is also known, that due to the complex nature of the ca19-9 antigen, ca19-9 results can differ significantly between different methods, caused by different reaction conditions in the different methods.

Manufacturer Narrative

During investigations, measurements of the provided samples were performed on a centaur system, confirming the roche test results for ca 19-9, ca 125 and cea.

• Brand Name: ELECSYS CA 19-9 IMMUNOASSAY
• Type of Device: TEST, CARBOHYDRATE ANTIGEN (CA19-9)
• 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: 6075338
• MDR Text Key: 59123783
• Report Number: 1823260-2016-01718
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K050231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 11776193122
• Device Lot Number: 164834
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/20/2016
• 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