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 06/03/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#:(b)(4). This event occurred in (b)(6).

Event Description

The customer received questionable elecsys ca 19-9 immunoassay results for qc material and one patient sample compared to the result from a siemens advia centaur system. The result from cobas e 411 immunoassay analyzer serial number (b)(4) was 16. 77 u/ml. On (b)(6) 2018, the sample sent to an external laboratory and was tested on a siemens advia centaur with a result of 36. 2 u/ml. On (b)(6) 2018, the sample was repeated on the cobas e411 with a result of 16. 16 u/ml and on a cobas 6000 e 601 module with a result of 16. 98 u/ml. The serial number was not provided. No erroneous result was reported outside of the laboratory. There was no allegation of an adverse event.

Manufacturer Narrative

Calibration signals for the assay were generally lower than those obtained during kit release. The last calibration ((b)(6) 2018) performed before the event were lower than those obtained during kit release. The customer's qc for the period 14-may-2018 through 01-jun-2018 were mostly between -1 and -3 sd; one value was out of range, low, for each level. No issues were seen with the customer's external proficiency data for january through may 2018. The analyzer's alarm trace for 10-may-2018 through 06-jun-2018 showed multiple alarms related to liquid level detection and positioning of the sample/reagent probe, magnet, and gripper. There were also multiple temperature and film detection alarms related to the reagent system. No patient sample was available for investigation. The assay method sheet contains the following disclaimer: the measured ca 19 9 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 19 9 assay method used. Ca 19 9 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 19 9 assay procedure used while monitoring therapy, then the ca 19 9 values obtained upon changing over to the new procedure must be confirmed by parallel measurements with both methods.

Manufacturer Narrative

The higher result from the centaur was believed to be correct as the patient was losing weight and had stomach aches. Close relatives of the patient had previously had stomach cancer.

• 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
• MDR Report Key: 7633510
• MDR Text Key: 112717133
• Report Number: 1823260-2018-02013
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• PMA/PMN Number: K050231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 11776193122
• Device Lot Number: 29340700
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No