MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS® CD A/B 60 TESTS

Catalog Number 30118

Device Problem Fracture (1260)

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

Event Type  malfunction  

Event Description

Product description: 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).Issue description: on (b)(4) 2024, a customer from argentina notified biomérieux of receiving the cdab positive control toxin b (c3) vial broken in the kit vidas cd a/b 60 tests (ref.(b)(4), lot: 1010178630, expiry date: 31-may-2024).At the opening of the box, the vial c3 was broken.According to customer, the issue did not cause any injury to the operator but led to a delay in delivering patient results.The number of impacted samples and the duration of the delay were not specified.There is no indication or report from the laboratory that the delayed results led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.Note: reference (b)(4) is not registered in the united states.The u.S.Similar device is product reference (b)(4).

Manufacturer Narrative

An internal investigation was performed following a notification from a customer from argentina who received the cdab positive control toxin b (c3) vial broken in the kit vidas cd a/b 60 tests (ref.(b)(4), lot: 1010178630, expiry date: 31-may-2024).1.Investigation outcomes.1.1.Analysis.The complaint analysis did not reveal this issue as a systemic quality issue.1.2.Quality control records.There is neither capa nor non-conformity linked to this issue on this vidas assay.1.2.Tests conducted by complaints laboratory.The complaints laboratory observed the integrity of different vials of standards and controls with the same lot as the ones from the kit vidas c.Difficile toxin a & b (cdab) lot 1010178630 coming from the retain kit and from quality control laboratory (remaining vials).Concerned components: s1 lot 2251160 exp 2025-02-14 =1 vial.C1 lot 2251190 exp 2025-02-14 =1 vial.C2 lot 2251180 exp 2025-02-14 =1 vials.C3 lot 2251170 exp 2025-02-14 =10 vial.R1 lot 2239220 exp 2025-01-09 =1 vial.No issue observed.2.Conclusion.The complaints laboratory has not reproduced the customer¿s issue during the test performed on components from the retain kit of vidas c.Difficile toxin a & b (cdab) lot 1010178630 and remaining vials of the same lots of controls.This kind of issue is monitored by the manufactured site.According to the investigation outcomes, the performance of the vidas cd a/b 60 tests (ref.(b)(4), lot: 1010178630) is conform to the expected specifications.

• Brand Name: VIDAS® CD A/B 60 TESTS
• Type of Device: VIDAS® CD A/B 60 TESTS
• 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: sandra locca-bernard ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 18580240
• MDR Text Key: 334765289
• Report Number: 8020790-2024-00001
• Device Sequence Number: 1
• Product Code: LLH
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30118
• Device Lot Number: 1010178630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1