MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV); ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Catalog Number 06368921190

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received a questionable negative result for two samples from the same patient tested with the elecsys anti-hcv ii immunoassay on a cobas e 411 immunoassay analyzer.The second sample was also tested on an e411 used at a second site.The questionable negative values were reported outside of the laboratory.The first sample was initially tested using a quick profile hcv antibody test card manufactured by (b)(4), resulting with a reactive result.This sample was tested on the e411 analyzer, resulting with a non-reactive value.The specific value generated on the e411 analyzer was not provided.The second sample was tested using the quick profile hcv antibody test card, resulting with a reactive result on 16-oct-2020.This sample was tested at a second site using an hcv rapid test strip manufactured by (b)(4), resulting with a positive result on 16-oct-2020.This sample was tested at a third site using an hcv ab plus rapid test strip manufactured by (b)(4), resulting with a positive result of 16-oct-2020.This sample was tested on the customer's e411 analyzer, resulting with a value of 0.06 coi (non-reactive) on 16-oct-2020.The sample was tested on an e411 analyzer at the second site, resulting with a value of 0.077 coi (non-reactive) on 16-oct-2020.The serial number of the customer's e411 analyzer is (b)(4).The serial number of the e411 analyzer used at the second site was requested, but not provided.

Manufacturer Narrative

The customer's calibration and qc were acceptable.Based on the available data, a general reagent issue is excluded.The patient's result with pcr methodology was negative.The negative elecsys anti-hcv ii result fits to the patient history and to the negative pcr result.Sample material was requested for investigation but was not available.No further testing could be performed.The investigation did not identify a product problem.

• Brand Name: ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV)
• Type of Device: ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10804549
• MDR Text Key: 215317901
• Report Number: 1823260-2020-02807
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• PMA/PMN Number: P140021
• 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: 12/01/2020

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 Catalogue Number: 06368921190
• Device Lot Number: 48035800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 10/16/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR