MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS TOXO IGG II 60 TESTS

Catalog Number 30210

Device Problem False Negative Result (1225)

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

Event Date 07/26/2021

Event Type  malfunction  

Event Description

Intended use: vidas® toxo igg ii is an automated quantitative test for use on the vidas family instruments for the quantitative measurement of anti-toxoplasma igg in human serum or plasma (lithium heparin or edta) using the elfa technique (enzyme linked fluorescent assay).Results and interpretation: titer (iu/ml) interpretation.< 4 negative.4 = titer < 8 equivocal.= 8 positive.Description of the issue: on 08-sep-2021, a customer in (b)(6) notified biomérieux of negative result when testing vidas® toxo igg ii 60 tests (ref.30210, lot #1008609560, expiry date: 25-january-2022) with a patient sample.The patient had previously carried out the test at another laboratory on the (b)(6) 2021 and the result was positive (the method is not known yet).The patient went the customer's laboratory and obtained a negative result with vidas toxo igg test lot #1008609560 on (b)(6) 2021.The patient then repeated the test at a third laboratory on (b)(6) 2021, and the result was positive.To be noted, the patient went back to this customer's laboratory, and the result was positive.The client is no longer in possession of the patient's serum, so he was unable to repeat the test.There is no indication or report from the laboratory that the issue led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be been initiated.Note: reference 30210 is not registered in the united states.The u.S.Similar device is product reference 30210-01.

Manufacturer Narrative

A customer in italy notified biomérieux of obtaining a negative result when testing a patient sample in association with vidas® toxo igg ii 60 tests (ref.30210, lot #1008609560, expiry date: 25-january-2022).Investigation review of the batch history record for the vidas toxo igg (lot 1008609560) showed no anomalies during the manufacturing, control, or packaging processes.No non-conformity nor capa is linked to the customer¿s complaint recorded on vidas toxo igg lot 1008609560.Control chart analysis.The investigator analyzed the control chart on 4 internal samples, using 7 batches (including the customer¿s).All values are within specifications and the customer¿s lot is consistent with the other lots.Biomérieux complaints laboratory tested 3 internal positive samples on retain kits of vidas toxo igg lot 1008609560 and lot 1008761450 (lot used by the customer for retesting of the sample).Sample results are within their expected specifications and similar to those observed before the batch release on both lots.There was no significant difference of the results observed between the 2 lots tested nor was there any evolution of results over time of the batch 1008609560.Conclusion.According to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data and the test performed on the retain kit of vidas toxo igg lot 1008609560.Biomérieux did not reproduce the vidas toxo igg negative result when testing positive internal samples on the retain kit vidas toxo igg.Customer confirmed that they did not have any additional material from the concerned sample available.Without the patient sample, it is not possible to pursue further the investigation.According to the data mentioned above, there is no reconsideration of vidas toxo igg ref 30210 lot 1008609560.

• Brand Name: VIDAS TOXO IGG II 60 TESTS
• Type of Device: VIDAS TOXO IGG II 60 TESTS
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy-l'étoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; 376 chemin de l'orme; marcy-l'étoile 69280 ; FR 69280
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12563190
• MDR Text Key: 283829224
• Report Number: 8020790-2021-00191
• Device Sequence Number: 1
• Product Code: LGD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K993319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2022
• Device Catalogue Number: 30210
• Device Lot Number: 1008609560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1