MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® D-DIMER EXCLUSION II ¿

Catalog Number 30455-02

Device Problem Nonstandard Device (1420)

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

Event Type  malfunction  

Event Description

Issue description: a customer from poland notified biomérieux of obtaining substrate error while using vidas d-dimer exclusion ii 60t (ref.30455-02, batch number: 1008744900).The customer reported substrate error occurred on vidas d-dimer exclusion ii 60t (ref.30455-02, batch number: 1008744900) to be noted that in case of substrate error, an error message is displayed on the equipment visible by the user, and it is impossible to run tests and generate results.The customer stated that 2 samples were sent to another lab leading to a delay in rendering result.The delay was 1 day.There is no indication or report from the laboratory that the substrate error led to any adverse event related to any patient's state of health.The lot impacted by this complaint is part of the scope of fsca #5333 released on 22-sep-2021 for substrate error on multiple vidas product references.A biomérieux internal investigation has been initiated.Note: product reference 30455-02 is not sold or distributed in the united states; however, a similar product (reference 30455-01) is registered and sold in the united states.

Manufacturer Narrative

Following an increase in customer complaints about ¿substrate error¿ on different vidas® references tested on all vidas systems, an internal investigation was performed.Investigation: device history record: the analysis of the batch history records of the vidas lots concerned showed no anomaly during the manufacturing, control, and packaging processes.No non-conformity linked to the customer¿s complaint was registered on these batches.Following the increase of complaints for substrate issues, a capa (corrective action preventive action) has been opened to identify the actions.Tests/analysis performed: the problem was detected on vidas, when the fluorescence is measured (first read) before the beginning of the tests.If there is a ¿substrate error¿, the user has an error message ¿ errors/substrate error¿ which displays on the equipment making it impossible to run tests and generate results.The ¿substrate error¿ issue has been observed 5 to 6 months after the date of manufacturing of the strips.During the investigation, it was confirmed that one lot of common raw material was used in all substrate batches contained in vidas® immuno-assays strips with a high level of complaints about ¿substrate error¿ and therefore this batch of raw material was identified as the most probable common root-cause.Investigation performed at the supplier level confirmed that a lot of raw material in cause is atypical and is indeed the source of substrate errors on vidas reagents.At the end of september 2021, the manufacturing site stopped the production of the kits with the concerned raw material lot.Root cause analysis and conclusion: the root causes linked to the specifications process at the supplier of the raw material have been identified.Corrective action will be implemented at the supplier to add some specifications and control in the manufacturing process of the raw material concerned.At biomérieux site, an incoming control with stability will be implemented as a preventive action.

• Brand Name: VIDAS® D-DIMER EXCLUSION II ¿
• Type of Device: VIDAS® D-DIMER EXCLUSION II ¿
• Manufacturer (Section D): BIOMERIEUX 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: ines el oueryemmi ; 5 rue des acqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 14306592
• MDR Text Key: 299834442
• Report Number: 8020790-2022-00055
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/05/2022

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: 05/07/2022
• Device Catalogue Number: 30455-02
• Device Lot Number: 1008744900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: A
• Removal/Correction Number: FSCA5333
• Patient Sequence Number: 1