MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® CMV IGG ASSAY

Catalog Number 30204

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Biomérieux performed an internal investigation.Instrument issue was excluded as qcv results conformed to specifications.Biomérieux also performed investigational testing with vidas lyme igg, lot 1007040560/191112-0.This included testing four internal sera and the returned customer sample.The internal testing included two negative and two low positive tests; all internal results were within specifications.The customer sample also obtained a positive result when tested internally.The customer sample was then rerun with the cmg igg assay, first without sample and then without spr; both results were negative with a result of less than or equal to 4 ua/ml, duplicating the customer's initial discrepant result.The investigation concluded the most likely cause of the false negative result was operator error due to absence of spr or sample.According the above data , the reagent vidas cmv igg lot 1007040560/ 191112-0 was within the expected performance specifications.

Event Description

A customer in the (b)(6) notified biomérieux of discrepant results associated with the vidas® cmv igg 60 tests (reference 30204, lot 1007040560).Product reference 30204 is not marketed, sold or distributed in the united states.The u.S.Similar product is reference 30204-01.On (b)(6) 2019 , the customer provided biomérieux with information regarding false negative results for a patient sample.The original result was less than 4 ua/ml, the sample was repeated and a result of 44ua/ml was obtained.The customer confirmed the incorrect test result had no adverse impact to the patient's state of health but did note a one day delay of obtaining test results.Product reference 30204 is not marketed, sold or distributed in the united states.The u.S.Similar product is reference 30204-01.

• Brand Name: VIDAS® CMV IGG ASSAY
• Type of Device: VIDAS® CMV IGG ASSAY
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• Manufacturer Contact: jennifer armstrong ; 595 anglum road; hazelwood, MO 63042 ; 3145068201
• MDR Report Key: 8966612
• MDR Text Key: 218747811
• Report Number: 8020790-2019-00052
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K920661
• 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: 09/05/2019

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: 11/12/2019
• Device Catalogue Number: 30204
• Device Lot Number: 1007040560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1