MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS® TOXO IGM

Catalog Number 30202

Device Problem False Positive Result (1227)

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

Event Date 03/10/2023

Event Type  malfunction  

Event Description

Product description: vidas® toxo igm is an automated qualitative test for use on the vidas® family instruments, for the detection of anti-toxoplasma igm in serum, using the elfa technique (enzyme linked fluorescent assay).Issue description: on (b)(6) 2023, a customer in italy notified biomerieux of potential false-positive results when using vidas® toxo igm, reference: 30202, lot#: 1009758970, (b)(6) 2023 when compared to additional vidas and other method (eclia roche) results.The customer noted the patient was a pregnant female.Sample type: serum.Collection date: (b)(6) 2023.Test execution date (b)(6)2023.The following results were reported: on (b)(6) 2023.Calibration valid: s1 average = 640 rfv, c1=2.32 tv and c2=0.16 tv.Vidas toxo igm sample=0.90 tv positive.Vidas toxo igg sample negative (no value).On (b)(6) 2023, patient's sample tested at other laboratories: lab1 eclia : lyme ig m = 0.32 tv negative.Lab2 : lyme ig m = 0.24 tv negative.The same patient sample was used for all tests.At the time of this assessment, there was no report of patient harm or incorrect treatment.The product, vidas® toxo igm reference: (b)(4) is not marketed, sold or distributed in the united states.However, a similar product, vidas® toxo igm reference: (b)(4) is marketed in the united states.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

On 13-mar-2023, a customer in italy notified biomerieux of potential false-positive results when using vidas® toxo igm reference (b)(4) lot 1009758970 (18-sep-2023) when compared to additional vidas and other method (eclia roche) results.A biomérieux internal investigation was initiated.Investigation 1.Device history record no non-conformity or capa was linked to the customer¿s complaint recorded on vidas toxo igm lot 1009758970.No anomaly occurred during the manufacturing, control and packaging processes.2.Complaint analysis no systemic quality issue was observed.3.Tests/analysis performed **product return from customer** frozen sample received (around 1 ml).**investigation protocol and obtained results** ¿ study of internal samples control charts: this analysis was carried out : - on four (4) internal negative samples - on seven (7) batches including the lot mentioned by the customer.- all values are within specifications, and the customer¿s lot is in the trend of the other lots.¿ test on internal samples our complaints laboratory tested three (3) internal negative samples on the retain kits of vidas toxo igm lot 1009758970 (customer¿s lot) and lot 1009654280 (other lot used as reference).- results obtained are within the acceptable ranges and similar to those observed before the batch release and between lots.There is no observed evolution over time of the batch.¿ test on return sample our complaints laboratory tested the returned sample on the retain kits of vidas toxo igm lot 1009758970 (customer¿s lot) and lot 1009586740 (other lot used as reference).- customer¿s sample is found respectively to 0.80 tv and 0.74 tv, positive on both lots.The customer¿s issue is not linked to a specific batch of vidas toxo igm.¿ interference search - our complaints laboratory tested the customer¿s sample on hbt tube (heterophilic blocking tube) : sample without treatment =0.80 tv, positive and sample after treatment= 0.39 tv, negative - results showed that there was a potential interference due to heterophilic antibodies.- our complaints laboratory performed a rheumatoid factor research on the customer¿s sample.- results showed that there was no interference due to rheumatoid factor.4.Root cause analysis and conclusion according to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data, and the tests performed on internal samples with vidas toxo igm lot 1009758970.Customer¿s result is reproduced by complaints laboratory with the sample on the lot mentioned by the customer lot1009758970, and on another lot 1009586740, indicting the customer¿s issue is not linked to a specific batch.The main potential root cause to explain the customer¿s issue is an interference due to heterophilic antibodies present in the patient sample.As mentioned in vidas toxo igm package insert : limitations of the method interference may be encountered with certain sera containing antibodies directed against reagent components.For this reason, assay results should be interpreted taking into consideration the patient's clinical history and the results of any other tests performed.According to the data mentioned above, there is no reconsideration of vidas toxo igm ref (b)(4) lot 1009758970.

• Brand Name: VIDAS® TOXO IGM
• Type of Device: VIDAS® TOXO IGM
• Manufacturer (Section D): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: matt floretta ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 16585288
• MDR Text Key: 312170082
• Report Number: 8020790-2023-00020
• Device Sequence Number: 1
• Product Code: LGD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K141133
• 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: 05/10/2023

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: 09/18/2023
• Device Catalogue Number: 30202
• Device Lot Number: 1009758970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 05/05/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female