MAUDE Adverse Event Report: BIOMERIEUX, SA VIDAS® TOXO IGM

Model Number 30202

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a false negative result when using the product vidas® toxo igm (ref.30202).The patient's sample had been tested three times, obtaining the following results: ·test 1: index 0.47 / negative, ·test 2: index 0.91 / positive, ·test 3: index 0.88 / positive.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in sweden notified biomérieux of a false negative result when using the product vidas® toxo igm (ref.30202).An investigation was performed.The analysis of the batch history records for vidas toxo igm kit reference 30202 lot 100581380 showed no anomaly during the manufacturing and control processes.The analysis of control charts of 7 internal samples (2 negative, 1 equivocal and 4 positive) on 14 batches of vidas toxo igm (including lot mentioned by customer), showed that all the results are within specifications.The vidas toxo igm (ref 30202) batch 100581380 is in the trend of the other batches.The complaint laboratory subscribes to external control programs such as ctcb (french eqa provider) for toxo igm.The complaint laboratory tested the ctcb 1731 sample from the 3rd campaign of 2017 on the vidas toxo igm lot and obtained a negative result with 0.05 tv as expected.The complaint laboratory tested a positive sample on the vidas toxo igm lot with some modifications at the pre-analytical level (no sample volume in the strip, no spr (solid phase receptacle), modification of sample volume by 50l or 150l instead of 100l, toxo igii spr instead of vidas toxo igm spr) and obtained the following results : normal condition : 1563 rfv / 2.88 tv , positive.No sample in the strip : 176 rfv/ 0.32 tv , negative.No spr : 1 rfv/ 0,00 tv negative.Modification of sample volume - 50l: 1464 rfv/ 2,70 tv positive.Modification of sample volume - 150l: 1451 rfv/ 2,68 tv positive.Vidas toxo igm test using vidas txg ii spr : 46 rfv / 0,08 tv negative.Moreover, quality control laboratory performed tests on the kit vidas toxo igm to simulate mistake during pre analytical step.In the absence of sample's volume, for a positive sample (861 rfv expected), the signal as well as the test value were greatly reduced (366 rfv / 0.57 vt with a negative serological status).Final conclusion : as it was not possible to get the sample, we cannot pursue further the investigation.The complaint laboratory suggests that the problem reported by the customer may come from a handling error during the pre-analytical step of the test vidas toxo igm reference 30202 (lack or absence of sample in the strip, spr missing or toxo igg ii spr used instead of toxo igm).According to all the data mentioned above, vidas toxo igm reference 30202 lot 100581380 / 180417-0 is within the expected specifications.

• Brand Name: VIDAS® TOXO IGM
• Type of Device: VIDAS® TOXO IGM
• Manufacturer (Section D): BIOMERIEUX, SA; 376 chemin de l'orme; marcy l'etoile, 69280 ; FR 69280
• MDR Report Key: 7060706
• MDR Text Key: 93611206
• Report Number: 3002769706-2017-00383
• Device Sequence Number: 1
• Product Code: LGD
• Combination Product (y/n): N
• PMA/PMN Number: K923166
• 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: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30202
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1