MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® C. DIFFICILE GDH

Catalog Number 30125

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

On (b)(6) 2023, a customer from poland reported to biomérieux that they observed negative results when testing patient sample with vidas gdh 60 tests (ref.30125, batch 1009606260.Expiry date 31-oct-2023) compared to another method.The customer performed test on one patient sample, he obtained the following results: clinical history: woman with diarrhea symptoms.(b)(6) 2023: gdh = 0.01 and 0.01 the customer tested the same sample on vidas cdab lot 1009724640; he obtained: cdab lot 1009724640 = 0.66 and 1.09 (positive results) he compared to another method (pcr), he obtained a positive results.At the time of this assessment, there is no indication or report from the laboratory that the issue led to any adverse event related to patient's state of health.A biomérieux internal investigation has been initiated.Note: reference 30125 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 in poland that he obtained negative results when testing a patient sample with vidas gdh 60 tests (ref.30125, batch 1009606260 expiry date 31-oct-2023) compared to another method.Investigation results 1.Device history record the review did not highlight any issue during manufacturing for vidas gdh ref 30125 lot 1009606260.2.Complaint analysis the complaint analysis did not reveal this issue as a systemic quality issue.3.Tests/analysis performed products return: the return of customer¿s samples was not possible because of the lack of stability of stool.Investigation protocol and obtained results: the tests were performed on available internal samples at complaint laboratory.Control charts analysis: the complaints laboratory analyzed the results: - of 6 internal samples including 5 positive and one negative, - on 7 different batches of vidas gdh ref 30125 including lot 1009606260 mentioned by the customer.The analysis of the control charts showed that all results were within specifications.Customer¿s lot is in the trend of the other lots.Tests performed by complaints laboratory: - on internal samples 6 internal samples including frozen stool and supernatant, were tested on vidas gdh ref 30125 lot 1009606260 (retain kit) and another batch with reference 1010013070.=> there is no change of interpretation whatever the sample or the batch used.The issue observed by customer, i.E.False negative results, was not reproduced.Conclusion of the investigation according to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data and the tests performed on retain kit vidas gdh ref 30125 lot 1009606260 using internal samples.Customer's issue, i.E.False negative results, was not reproduced by complaints laboratory during the investigation conducted on internal samples materials.The investigation did not manage to identify any obvious root cause.Without customer¿s returned sample and kit, biomérieux cannot pursue the investigation any further.According to the above information, there is no reconsideration of the performance of vidas gdh ref 30125 lot 1009606260.

• Brand Name: VIDAS® C. DIFFICILE GDH
• Type of Device: VIDAS® C. DIFFICILE GDH
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'étoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMÉRIEUX; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: inès el oueryemmi ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16751407
• MDR Text Key: 313415302
• Report Number: 8020790-2023-00027
• Device Sequence Number: 1
• Product Code: MCB
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K132010
• 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: 06/15/2023

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: 10/31/2023
• Device Catalogue Number: 30125
• Device Lot Number: 1009606260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 06/04/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female