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

Catalog Number 30455-02

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Event Description

On (b)(6) 2022, a customer in germany notified biomérieux of obtaining a possible too high value when using vidas® d-dimer exclusion ii 60t (ref.30455-02, lot number 1009306490, expiry date 21-mar-2023) with a patient sample.The customer reports that the patient, aged of 76 years old, has a too high d-dimer value: 1447.19 ng/ml.However, the physician does not believe this based on the patient's history.The patient is receiving a medication related to heart failure.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.A biomérieux internal investigation was opened.Note: reference 30455-02 is not sold or distributed in the united states.However, there is a similar device, u.S-only product reference, 30455-01.

Manufacturer Narrative

This report was initially submitted following notification from a customer in germany regarding a possible too high value when using vidas® d-dimer exclusion ii 60t (ref.30455-02, lot number 1009306490, expiry date 21-mar-2023) with a patient sample.A biomérieux internal investigation has been completed with the following results: investigation: 1.Device history record.The review did not highlight any issue during manufacturing for vidas® d-dimer exclusion ii 60t - 30455-02 lot 1009306490.There was no capa, no non conformity on vidas® d-dimer exclusion ii 60t - 30455-02 linked with customer¿s complaint.2.Complaint analysis: the complaint analysis did not reveal this issue as a systemic quality issue.3.Tests/analysis performed: products return: no material from customer available.Investigation protocol and obtained results: the tests were performed on internal samples available at complaints laboratory.Control charts analysis: the complaints laboratory analyzed the results: - of 4 internal samples targeted at 134, 585, 1277 and 1341 ng/ml - on 7 different lots including vidas® d-dimer exclusion ii 60t - 30455-02 lot 1009306490 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 - 4 internal samples targeted at 134, 585, 1277 and 1341 ng/ml were tested on vidas® d-dimer exclusion ii 60t - 30455-02 lot 1009306490 (retain kit).The results complied with the specifications without any significant difference compared to those observed before the lot release.Biomérieux did not observe any evolution over time of these samples activity.According to the package insert, chapter limitations of the method: ¿ ¿interference may be encountered with certain plasmas containing antibodies directed against reagent components.For this reason, assay results should be interpreted taking into consideration the patient's history (clinical probability).¿ 4.Root cause analysis and conclusion: the tests performed on the retain kit on vidas® d-dimer exclusion ii 60t - 30455-02 lot 1009306490 using internal samples.Unfortunately, the investigation did not manage to identify any obvious root cause.Without customer¿s return sample and kit, biomérieux cannot pursue investigation.The vidas d-dimer exclusion ii assay is indicated for use in conjunction with a clinical pre-test probability assessment model to exclude deep vein thrombosis (dvt) and pulmonary embolism (pe) disease in outpatients suspected of dvt or pe.According to the customer¿s feedback, the clinical context was not in favor of dvt or pe suspicion and the patient is elderly.In venous thromboembolism (vte) patients, the lysis of obstructing blood clots results in increased plasma d-dimer levels.However, d-dimer is not specific for vte and elevated levels are also observed in a variety of other clinical conditions where activation of coagulation and fibrinolysis occurs according to the above data, vidas® d-dimer exclusion ii - 30455-02 lot 1009306490 is within the expected performance.

• Brand Name: VIDAS® D-DIMER EXCLUSION II ¿
• Type of Device: VIDAS® D-DIMER EXCLUSION II ¿
• 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: romain marti ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15536704
• MDR Text Key: 301119872
• Report Number: 8020790-2022-00101
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2023
• Device Catalogue Number: 30455-02
• Device Lot Number: 1009306490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1