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 Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer stated qc was within specification.The investigation determined that there was reagent contamination, which occurred during the filling process of the elecsys ca 19-9 reagent cassettes lot number: 483123 for the cobas e 801 module only.The issue is related to contamination of the reagent with magnetic particles.Roche has provided two work-around 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.Instructions for implementing these workarounds were communicated to customers by customer notification.

Event Description

The initial reporter received questionable ca 19-9 elecsys e2g results for 1 patient sample on a cobas 8000 e 801 module, serial number: (b)(4).The initial result was 37 u/ml.The result was reported outside of the laboratory.On (b)(6) 2020, the sample was repeated, and the result was 15 u/ml.This result was believed to be correct.

• 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: 10896062
• MDR Text Key: 220964305
• Report Number: 1823260-2020-02991
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 11/24/2020

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 Model Number: CA 19-9 ELECSYS E2G
• Device Catalogue Number: 07027028190
• Device Lot Number: 483123
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/24/2020
• 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
• Removal/Correction Number: RES 84915
• Patient Sequence Number: 1