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

Catalog Number 30202

Device Problem False Negative Result (1225)

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

Event Date 06/29/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, a customer from the (b)(6) reported to biomérieux that they observed false negative results when testing a patient sample with vidas toxo igm 60 tests (ref.30202, batch 1008442120, expiry date 21-sep-2021) compared to other methods.The customer obtained the following results with the same patient serum sample: vidas toxo igm 60 tests : 0.4 tv (negative interpretation).This result was obtained on (b)(6) 2021 and was preceded by a valid calibration.Cobas from roche : 1.10 tv (positive interpretation - cut-off of 1.00 tv).Method from siemens : 1.4 tv (positive interpretation ¿ cut-off of 1.00 tv).Method from beckman coulter : 1.4 tv (positive interpretation ¿ cut-off of 1.00 tv).It was reported that a pcr was performed at an external laboratory and was negative.At time of reporting, there was no evidence of any patient harm or incorrect treatment due to the reported false negative results.A biomérieux internal investigation will be initiated.Note: reference 30202 is not registered in the united states.The u.S.Similar device is product reference 30202-01.

Manufacturer Narrative

A customer in korea notified biomérieux that they obtained a (suspected) false negative result while testing a patient sample with vidas toxo igm (ref (b)(4)/lot 1008442120).The sample was positive using other methods.Investigation the investigation reviewed the batch history record for vidas toxo igm lot 1008442120.This review did not reveal any anomalies during the manufacturing, control and packaging processes.The investigation confirmed that no other reports have been received for a false negative result using the customer¿s lot.Additionally, no non-conformities, nor capas, were linked to the customer's complaint.The customer stated that they were unable to submit the sample to biomérieux for investigation as there was not enough material left.The investigation reviewed the control charts on four internal samples (1 sample with a negative target and 3 with a positive one) using seven test lots (including the customer¿s lot).All values are within specifications; customer's lot is consistent with the other lots.The complaints laboratory tested four internal samples (1 sample with a negative target and 3 with a positive one) on retain kits from the customer¿s lot.Samples results are within the expected specification.No significant difference of their activity was observed, compared to those observed before the batch release.According to all information above, no anomaly was highlighted with the control chart analysis and the analysis of quality data of vidas toxo igm lot 1008442120.Biomérieux did not reproduce the vidas toxo igm negative result when testing positive internal samples on the retain kit of customer's vidas toxo igm lot.All the results comply with expectations.Without any concerned sample available, further investigation cannot be pursued.According to the data mentioned above, there is no reconsideration of vidas toxo igm ref (b)(4)/lot 1008442120.

• 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: 12284786
• MDR Text Key: 283633100
• Report Number: 8020790-2021-00174
• Device Sequence Number: 1
• Product Code: LGD
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2021
• Device Catalogue Number: 30202
• Device Lot Number: 1008442120
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1