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 Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received a questionable elecsys ca 19-9 immunoassay results for one patient.The patient had been moved from another hospital and the result for ca19-9 at that hospital using an architect analyzer had been 100 u/ml.The specific date of testing was unknown.The patient was then tested on cobas 8000 e 602 module serial number (b)(4) and the result was 30 u/ml.Information concerning if any erroneous result was reported outside the laboratory was requested but it was unknown.There was no allegation of an adverse event.Sample from the patient was submitted for investigation and tested on a roche analyzer.The result was 30.87 u/ml.The same sample was sent to another laboratory for testing on an architect analyzer and the result was 124 u/ml.A specific root cause could not be determined as additional sample material was not available for further investigation.Based on the results of the testing, the root cause was possibly due to the difference in the reaction for the sugar chain's antigen.Interference in the sample was excluded based on the results from a neuraminidase test.Product labeling for the assay states that single ca 19-9 results from different assay formats must not be directly compared to each other, because different methods may report different results.In case of a change in method, several parallel measurements are highly recommended.

• 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: 6559299
• MDR Text Key: 74902566
• Report Number: 1823260-2017-00976
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other
• Type of Report: Initial
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11776193122
• Device Lot Number: 16842400
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/09/2017
• Initial Date FDA Received: 05/10/2017
• 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