MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CMV IGG ASSAY; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Catalog Number 04784596190

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Sample material was requested for investigation.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys cmv igg (cmv igg) on a cobas 6000 e 601 module.The result from the e601 module was < 0.150 u/ml (negative) with a data flag.The sample was repeated by the abbott, liaison and vidas methods with the following results: abbott: 14.7 u/ml (positive), liaison: 24 u/ml (positive), vidas: 8 u/ml (positive).On (b)(6) 2020 the result from the e601 module was < 0.150 u/ml (negative).This sample was also repeated by the abbott, liaison and vidas methods with the following results: abbott: 17 u/ml (positive), liaison: 26 u/ml (positive), vidas: 6 u/ml (positive).The roche results were reported outside of the laboratory.The e601 module serial number was (b)(4).

Manufacturer Narrative

The sample was received for investigation and tested with cmv igg reagent 450074 on an e602 module.The customer's negative cmv igg results were reproduced.

Manufacturer Narrative

The customer's calibration recovery was found to be acceptable.The customer's qc recovery was found to be acceptable.The provided sample was tested using a recomline cmv igg blot.The blot testing found the sample to show no cmv specific reactivity (negative result), which confirms the negative result the customer previously received onsite.The investigation found the cmv igg assay to be performing within specifications.

• Brand Name: ELECSYS CMV IGG ASSAY
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10475868
• MDR Text Key: 221591039
• Report Number: 1823260-2020-02147
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• PMA/PMN Number: K131605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 04784596190
• Device Lot Number: 450074
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1