MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS® C. DIFFICILE TOXIN A & B

Catalog Number 30118

Device Problem Nonstandard Device (1420)

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

Event Type  malfunction  

Event Description

Intended use: the vidas c.Difficile toxin a & b (cdab) assay is an automated test for use on the vidas family instruments for the qualitative detection of clostridium difficile toxin a and toxin b in stool specimens using the elfa technique (enzyme-linked fluorescent assay).The vidas c.Difficile toxin a & toxin b (cdab) assay is an aid for diagnosing clostridium difficile associated disease (cdad).Results: (b)(6).Description of the issue: on (b)(6) 2022, a customer in germany notified biomérieux of an unusable calibration vial leading to delayed results when testing with vidas® cd a/b 60 tests (ref.30118, lot #1008995940; expiry date: 19-aug-2022) with patient samples.The customer has opened a package and he saw that the c1 solution was flocked.The customer has vortexed the c1 and there were still flakes.The customer noticed a delay higher than 24 hours in rendering the results.The is no information about the number of impacted patients.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.Note: reference # 30118 is not registered in the united states.The u.S.Similar is product reference # 30118-01.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

A biomérieux internal investigation was performed following complaint from a customer from germany that they observed a visual defect in the c1 kit control from vidas cda/b ref.30118 lot 1008995940.The c1 kit control contained glitters at the opening the vial.The other kits controls c2 and c3 have a normal appearance.Investigation.1.Device history record.There is neither capa nor non-conformity recorded on this vidas assay in link with the customer's issue.2.Complaint analysis.The complaint analysis did not reveal this issue as a systemic quality issue.3.Test/analysis performed.Customer¿s material.For investigation, the opened box from the customer vidas cda/b ref.30118 of the lot 1008995940 was received with: - 50strips; - 2 bags of strs one is closed and the other is open and badly closed; - 1 kit control c1 and an aliquot with glitters; - 1 kit control c2 and an aliquot with normal appearance; - 1 kit control and an aliquot of normal appearance; - 1 vial of diluent r1.Tests performed by complaint laboratory.- the complaint laboratory has observed c1 kit control on retain kit vidas cda/b ref.30118 of the lot 1008995940, c1 has a normal appearance.- the complaint laboratory has observed 8 vials of c1 kit control same lot from quality control laboratory.One vial c1 kit control as the same aspect than the customers with glitters.- the complaint laboratory tested the c1 kit control with glitters from quality control laboratory on retain kit vidas cda/b ref.30118 of the lot 1008995940 (with c1 control kit normal).The calibration was valid.The c1 kit control of the calibration as the same result that the c1 kit control with glitters.The c1 result is similar of the result obtained during the quality control.- the complaint laboratory performed the calibration with customer¿s return kit.The calibration is valid c1 kit control has the result similar to result obtained during the quality control investigation by the industrialization department.The origin of the presence of particles is linked to one batch of the consumable (brown bottle ref.03587041) used for the distribution of the c1 reagent.There is a consumable item supplied by an external company.Therefore, the issue is not linked to biomérieux manufacturing process.Supplier's investigation, the root cause is a failure of the equipment for the production of the batch of vials.4.Root cause analysis and conclusion.According to all the above information, no anomalies were detected during the analysis of the quality data on vidas cda/b ref.30118 lot 1008995940.It is possible to observe the glitters in the c1 kit control.There is no impact on the quality of the results provided.The root cause is an equipment failure in the production of the vial batch at our supplier.According to the above data, the vidas cda/b kit ref.30118 lot 1008995940 still meets the expected performance.

• Brand Name: VIDAS® C. DIFFICILE TOXIN A & B
• Type of Device: VIDAS® C. DIFFICILE TOXIN A & B
• Manufacturer (Section D): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l¿etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; 376 chemin de l'orme; marcy l¿etoile 69280 ; FR 69280
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13892838
• MDR Text Key: 297807145
• Report Number: 8020790-2022-00042
• Device Sequence Number: 1
• Product Code: LLH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080931
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2022
• Device Catalogue Number: 30118
• Device Lot Number: 1008995940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1