• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMERIEUX SA VIDAS® CMV IGG ASSAY Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8966612
MDR Text Key218747811
Report Number8020790-2019-00052
Device Sequence Number1
Product Code LFZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K920661
Number of Events Reported1
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 Date11/12/2019
Device Catalogue Number30204
Device Lot Number1007040560
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/08/2019
Initial Date FDA Received09/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-