MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS D-DIMER EXCLUSION II 60T

Catalog Number 30455-02

Device Problem Nonstandard Device (1420)

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

Event Type  malfunction  

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.

Event Description

Intended use: vidas® d-dimer exclusion ii¿ is an automated quantitative test for use on the instruments of the vidas® family for the immunoenzymatic determination of fibrin degradation products (fbdp) in human plasma (sodium citrate) using the elfa technique (enzyme linked fluorescent assay).Vidas® d-dimer exclusion ii¿ is indicated for use in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (dvt) and pulmonary embolism (pe) disease in outpatients suspected of dvt or pe.Vidas® d-dimer exclusion ii¿ is indicated for use in the herdoo2 clinical decision rule (cdr) to assess the risk of recurrence of venous thromboembolism (vte) in women with a first unprovoked vte.Risk stratification by this cdr is an aid to guide the duration of oral anticoagulant therapy.Issue description: on (b)(6) 2022, a customer from argentina notified biomérieux of obtaining substrate error while using vidas d-dimer exclusion ii 60t (ref.(b)(4) batch number: 1008756000).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 was unable to send the samples to another lab, that led to a delay on rendering result between 48 hours and 72 hours.8 samples were impacted by this delay.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 (b)(6) 2021 for substrate error on multiple vidas product references.The expiry date was revised and is: (b)(6) 2022.

• Brand Name: VIDAS D-DIMER EXCLUSION II 60T
• Type of Device: VIDAS D-DIMER EXCLUSION II 60T
• 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: candace martin ; 595 anglum road; hazelwood, MO
• MDR Report Key: 14502491
• MDR Text Key: 300735049
• Report Number: 8020790-2022-00065
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2022
• Device Catalogue Number: 30455-02
• Device Lot Number: 1008756000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Removal/Correction Number: FSCA 5333
• Patient Sequence Number: 1