MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. COBAS EGFR MUTATION TEST; EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE MUTATION/ MRNA EXPRESSION IVD, NAT

Catalog Number 06471463190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 12/20/2013

Event Type  No Answer Provided  

Event Description

A customer site in taiwan filed a complaint alleging that discrepant results were generated with the cobas egfr mutation test, batch s06809.The customer tested two samples on (b)(6) 2013 and they both detected exon 20 insertions.They reran these two samples and the repeated results did not detect exon 20 insertions.This mdr is being filed for sample 2.Mdr 2243471-2014-00001 is filed for sample 1.The associated us product is m/n 06471463190 p120019.

Manufacturer Narrative

A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing.The outcome of this investigation will be communicated through a follow-up report.Note: product code nqf was selected as the closest available code.Nqf is immunohistochemistry assay egfr.The product in this mdr is a nucleic acid test (nat) for egfr.(b)(4).

• Brand Name: COBAS EGFR MUTATION TEST
• Type of Device: EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE MUTATION/ MRNA EXPRESSION IVD, NAT
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC.; 1080 u.s. hwy. 202s; branchburg NJ 08876 373
• Manufacturer Contact: vincent stagnitto ; 1080 u.s. hwy. 202s; branchburg, NJ 08876-3733 ; 9082537569
• MDR Report Key: 3843074
• MDR Text Key: 4406948
• Report Number: 2243471-2014-00002
• Device Sequence Number: 1
• Product Code: OWD
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/30/2013

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: Other
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 06471463190
• Device Lot Number: S06809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2013
• Initial Date FDA Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1