MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CA 19-9 ELECSYS E2G; CARBOHYDRATE ANTIGEN (CA19-9) TEST SYSTEM

Model Number CA 19-9 ELECSYS E2G

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation determined that there was reagent contamination, which occurred during the filling process of the elecsys ca 19-9 reagent cassettes lot number 416245 for the cobas e 801 module only.The issue is related to contamination of the reagent with magnetic particles.A replacement lot is not currently available.Roche has provided two workaround options to customers.The first workaround is customers may discontinue running the elecsys ca 19-9 assay on the e801 and instead run the ca 19-9 assay on the cobas e 411 analyzer, cobas e 601 and 602 modules, or the modular analytics e 170 module.The second workaround is customers can continue to run the ca 19-9 assay on the e801 and repeat all results =37 u/ml within 2 hours.Customers are also instructed to use only the first 200 determinations of the 300 test cobas e pack.Instructions for implementing these workarounds were communicated to customers by customer notification.

Event Description

The initial reporter complained of a discrepant high result for 1 patient tested for elecsys ca 19-9 (ca 19-9) on a cobas e801 module.The initial result was 116 u/ml.This result was reported outside of the laboratory.The sample was repeated twice with results of 7.17 u/ml and 7.4 u/ml.The repeat results were believed to be correct.The e801 module serial number was (b)(4).

• Brand Name: CA 19-9 ELECSYS E2G
• Type of Device: CARBOHYDRATE ANTIGEN (CA19-9) 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: 10137491
• MDR Text Key: 199989837
• Report Number: 1823260-2020-01404
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2020

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 Expiration Date: 01/31/2021
• Device Model Number: CA 19-9 ELECSYS E2G
• Device Catalogue Number: 07027028190
• Device Lot Number: 416245
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/10/2020
• 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
• Removal/Correction Number: 1823260-02/05/20-001-C
• Patient Sequence Number: 1