MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS CMV IGG 60 TESTS; VIDAS® CMV IGG 60 TESTS

Catalog Number 30204

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: vidas cmv igg is an automated quantitative enzyme immunoassay for use on the vidas family instruments for the quantitative measurement, of anti-cytomegalovirus igg (cmvg) in human serum, using the technique elfa (enzyme linked fluorescent assay).Results interpretation: value (au/ml) interpretation <4 negative =4 and =6 equivocal =6 positive the vidas® 3 system is a complete standalone immunodiagnostic system intended for trained and qualified laboratory technicians (daily routine use) and laboratory administrators (application configuration).Issue description on (b)(6) 2021, a customer from (b)(6) reported to biomerieux that they observed invalid results for four patient samples tested with vidas cmv igg 60 tests, (ref.30204, lot 1008569000, expiry date = 31-dec-2021) using vidas® 3 system (ref.412590, serial number (b)(4)).The following patient samples were flagged invalid by vidas 3 system due to an error message ¿3004xsft1 error¿: the system alerted the customer that the samples are overdiluted when in fact they were not diluted at all: (b)(6).It is reported that calibration and controls were valid before each test.As a consequence of this issue, there were delayed results of over 24 hours for these 4 patients.There is no indication or report from the laboratory that the delayed results led to any adverse event related to any patient's state of health.Note: reference 30204 is not registered in the united states.The u.S.Similar device is product reference 30204-01.

Manufacturer Narrative

An internal investigation was performed.Investigation results: findings from past investigation: despite numerous tests, the issue was never reproduced internally.The investigators have worked on customers¿ material (full system back-up, concerned patients¿ samples, customer¿s reagents).The problem occurs randomly at several customers¿ sites.To date biomérieux is still monitoring the incidence of this issue.As the software delivers invalid results, there is no risk of false results and the potential impact would be delay of result if user cannot get valid results with repeated tests, or when user had no alternative solution in short time.Despite the root cause not being identified, as an improvement, logs will be added to have more information into the next version of vidas 3 software (version (b)(4)).This version will also embed software change to improve behavior and workaround the consequence of the problem.The new software version can be implemented at the customer site.Conclusion: no root cause identified.The issue is not reproduced internally.There is no increasing number of complaints for similar issues.

• Brand Name: VIDAS CMV IGG 60 TESTS
• Type of Device: VIDAS® CMV IGG 60 TESTS
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 12451464
• MDR Text Key: 283503654
• Report Number: 8020790-2021-00186
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• PMA/PMN Number: K920661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 30204
• Device Lot Number: 1008569000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1