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

Catalog Number 30204

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of obtaining a false negative result for a patient sample in association with the vidas® cmv igg 60 tests (ref.30204, lot 1007495720).The customer stated the patient¿s serum sample obtained a result of 1.55 (unit not reported) when tested with the vidas® cmv igg 60 tests.The customer tested the patient sample using another test method(test performed not reported) which was positive for cmv.The positive result was reported to the physician.The customer confirmed there was a delay of less than one day in reporting results to the treating physician.However, there is no indication or report from the laboratory that the delay led to any adverse event related to the patient's state of health.Biomérieux will initiate an internal investigation.Note: reference 30204 is not registered in the united states.The u.S.Similar device is product reference 30204-01.

Manufacturer Narrative

This report was initially submitted following notification from a customer in belgium who notified biomérieux of obtaining a false negative result for a patient sample in association with the vidas® cmv igg 60 tests (ref.30204, lot 1007495720).Additional data have been obtained from this customer and it appears that there was no occurrence of false negative result.However, the customer reported a delayed result of 10-14h related to a software issue (software version: v 1.2.0.32) when running cmv igg assay for a patient¿s sample on vidas 3 instrument.Indeed, the launched run was flagged with the following error message: ¿sample over diluted¿, suggesting that the concerned sample might be over-diluted by the customer, although the customer did not dilute this sample.Due to the error message, no result was displayed because no calculation of concentration was possible, leading to delayed result.An investigation was conducted which included a review of the full system backup data sent from the customer, nothing abnormal was detected.Biomerieux investigators also conducted numerous tests in an attempt to replicate the error message however the issue could not be reproduced internally.Data review from associated complaints indicated that this anomaly occurred randomly for vidas 3 instruments using software versions 1.3.The risk associated with this error message was assessed and found to be minor.As a result of this error message, no result is released therefore there is no risk of obtaining an incorrect result.Despite the fact that the root cause has not been identified, biomerieux plans to add additional logs into the vidas 3 software version 1.4 to capture interactions between the vidas 3 software and the computation engine.Additionally, a work around will be developed in the event that the error message is displayed for an undiluted sample.See section h10.

• Brand Name: VIDAS CMV IGG 60 TESTS
• Type of Device: VIDAS® CMV IGG 60 TESTS
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 9649588
• MDR Text Key: 207751469
• Report Number: 8020790-2020-00008
• 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,Followup
• Report Date: 09/01/2020

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: 06/12/2020
• Device Catalogue Number: 30204
• Device Lot Number: 1007495720
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1