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 Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter received questionable elecsys ca 19-9 immunoassay results for one patient sample from the cobas e 801 module.The initial result was 140 u/ml.The repeat results were <6 u/ml and 6 u/ml.Since the previous result for the patient a year ago was <6 u/ml, the customer reported <6 u/ml to the physician.The reagent lot number was 352496.The expiration date was requested but was not provided.

Manufacturer Narrative

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.Medwatch fields d1, d2, d4, g1, g5, and h9 were updated.

• 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
• MDR Report Key: 9519595
• MDR Text Key: 219778708
• Report Number: 1823260-2019-04517
• 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
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA 19-9 ELECSYS E2G
• Device Catalogue Number: 07027028190
• Device Lot Number: 416245
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1823260-02/05/20-001-C
• Patient Sequence Number: 1