MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® TOXO IGM

Catalog Number 30202

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of obtaining false negative results for two separate patients in association with the vidas® toxo igm 60 tests (reference 30202, lot 1005927970) specifically the test strip lot 1806070.The customer stated that both patients tested positive for toxoplasma when tested with vidas ® toxo igg and western blot assays.The customer confirmed the incorrect results were reported to the treating physician, but did not result in any patient harm or mistreatment.A biomérieux internal investigation has been initiated.Note: reference 30202 is not registered in the united states.The u.S.Similar device is product reference 30202-01 (vidas toxo igm).

Manufacturer Narrative

This report was initially submitted following a customer report of obtaining false negative results for two separate patients in association with the vidas® toxo igm assay (reference 30202, lot 1005927970) specifically for the test strip lot 1806070.The customer reported, in total, false negative results for five different patients with seven impacted lots of the vidas toxo igm assay.According to diagnostic and clinical context, the biologist states that samples correspond to fresh infection.The customer used a panel of testing methods: vidas toxo igg, vidas toxo igm, vidas toxo avidity; western blot mikrogen igg, igm, avidity; toxo isaga igm (biomérieux).An internal biomérieux investigation was initiated.The patient samples were requested for the investigation, but were not submitted by the customer.The investigation included a review of batch history records, complaint trend analysis, a review of internal control charts, and an analysis of the data submitted by the customer by an internal expert.The impacted lot in this report expired prior to internal testing; therefore, another lot was used to test internal samples.Study of batches history record: there is no capa nor non conformity recorded on vidas txm ref 30202 linked to customer's issue.The analysis of the batch history records for vidas txm ref 30202 lots 1005927970/180607-0, 1006192450/181009-0, 1006329540/181210, 1006733100/190603, 1006817550/190714-0, 1006932330/190903-0 and 1006986180/190921-0 shown no anomaly during the manufacturing, control and packaging processes.Complaint trend analysis: the review found no other complaint about false negative results with the vidas toxo igm assay (ref 30202) on all lots mentioned by customer.There was no recurrence of the customer's issue.Control charts analysis: the complaint laboratory observed : four internal samples, low positive results (target 0.79 - 0.85 - 0.85 - 0.89 tv).On 28 different batches of vidas txm ref 30202 including the seven lots mentioned by the customer (1005927970/180607-0, 1006192450/181009-0, 1006329540/181210, 1006733100/190603, 1006817550/190714-0, 1006932330/190903-0 and 1006986180/190921-0) the analysis of the control charts showed that all results are within specifications.Customer's lots are in the trend of the other lots.Tests performed by complaint laboratory: the complaint laboratory tested with retain kits vidas toxo igm assay ref 30202 lots 1006932330/190903-0 and 1006986180/190921-0.All other lots mentioned by the customer were expired.All internal samples tested had final interpretation results within specification.Expert answer: without patient samples return, it was not possible to pursue investigations and to do complementary tests.For one of the patients, the vidas igg increase between different samples can be due to a recent infection.An isaga and another igg detection technique would have been required to confirm.No further conclusions could be drawn from the information provided.According to expert, avidity goes from low to high between four (4) to 12 months after infection.So if avidity is low, no conclusions can be made with this method.Moreover, in package insert vidas® toxo igg avidity ref 30222 in results and interpretation : an index lower than 0.300 does not enable a recent infection to be differentiated from an old infection.These samples should be retested using other markers or techniques." conclusion: without customer's return sample, we cannot pursue further investigation according to the information above, the vidas toxo igm assay is within the expected performances.Package insert reminder: vidas toxo igm ref 30202 results and interpretation : interpretation of test results should be made taking into consideration the patient's history, and the results of any other tests performed or other igm assay methods.As no international standard is available for the determination of anti-toxoplasma igm, the vidas toxo igm reagent is calibrated against collection sera.Equivocal samples (indices between 0.55 and 0.65) should be retested.If the interpretation remains equivocal, a new sample must be collected.Limitations of the method: since the persistence of anti-toxoplasma igm for several months or several years after seroconversion is a regularly described phenomenon, it is not possible to confirm recent infection, based solely on the presence of anti-toxoplasma igm, without taking into account the serological history of the patient.

• Brand Name: VIDAS® TOXO IGM
• Type of Device: VIDAS® TOXO IGM
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• MDR Report Key: 8935337
• MDR Text Key: 218747231
• Report Number: 8020790-2019-00043
• Device Sequence Number: 1
• Product Code: LSR
• Combination Product (y/n): N
• PMA/PMN Number: K141133
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2018
• Device Catalogue Number: 30202
• Device Lot Number: 1005927970
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1