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

Catalog Number 30455-02

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) reported to biomérieux that they observed a delayed over-estimated result while using the vidas® d-dimer exclusion ii 60t (reference # 30455-02, lot 1008696080, expiry date: 13 apr 2022) with a patient sample.The patient is a (b)(6) child who is suffering from dengue for last few days (as of reporting date).No other information on the patient is available.The customer reported that after a first result at 1250 ng/ml, the clinician was not satisfied with the result.The clinician decided to repeat the test the day after with a second sample from the patient, and the result was 970 ng/ml.Both sample results are over the threshold of 500 ng/ml; therefore, the interpretation for exclusion of dvt or pe is the same.There is no indication of monitoring of severity of dengue disease.The customer reported a delayed result of more than 24 hours.No result with a competitor method was reported.Date of last preventive maintenance, date of qcv testing and calibration report were not provided.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A biomerieux internal investigation was performed following notification from a customer from india that they observed a delayed over-estimated result while using the vidas® d-dimer exclusion ii 60t (reference # 30455-02, lot 1008696080, expiry date: 13 apr 2022) with a patient sample.1) customers material: no sample was received from customer.2) investigation outcomes.2-1) complaint analysis: up until now, only the customer¿s complaint for performance issue on vidas d-dimer exclusion ii lot 1008696080 was recorded.2-2) quality control records: the review of the different quality control records did not highlight any issue during manufacturing, control and packaging processes on vidas d-dimer exclusion ii lot 1008696080.2-3) analysis and tests conducted by complaints laboratory.Control chart analysis.This analysis was carried out: on four (4) internal samples with a respective target at 202 / 585 / 1372 and 3361 g/dl.On seven (7) batches of vidas d-dimer exclusion ii ref.(b)(4) including lot 1008696080 mentioned by the customer.The analysis of the control charts showed that all results are within specifications and vidas d-dimer exclusion ii lot 1008696080 is in the trend compared to the other lots.Test on internal samples: the complaints laboratory tested four (4) internal samples with a respective target at 202; 585; 1372 and 3361 ng/ml on vidas d-dimer exclusion ii lot 1008696080 (retain kit).The results complied with the specifications without any significant difference compared to the results observed before the batch release.No evolution over time of these samples activity was observed.The complaints laboratory tested an internal sample with target at 1372 ng/ml (close to the initial result observed by the customer) 8 times (repeatability testing) on vidas d-dimer exclusion ii lot 1008696080 (retain kit).All the results were within the acceptable range, the repeatability testing gave a mean at 1359.79 ng/ml (close to its target) and a cv at 1.18%, which is compliant with the specification (in the package insert the repeatability cv mentioned is between 1.5 and 2.5 %).Conclusion: the complaints laboratory did not reproduce the customer¿s anomaly, namely non-reproducible elevated results when testing internal samples on vidas d-dimer exclusion ii lot 1008696080.All the results obtained (either single test or repeatability testing) complied with expectations.No obvious root cause was identified.However, the results observed by the customer were obtained using 2 samples collected at different times and collected on a patient suffering from dengue infection.The results observed by the customer can be due for a part to: the blood-draw step itself because d-dimer outcomes are sensitive to the pre-analytical step and especially blood collection phase.For reminder, it is important to avoid any formation of micro clot of fibrin, which will lead to in vitro increase of d-dimer.The clinical context of the patient, which leads to inflammatory syndrome.As mentioned in the package insert, ¿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¿.D-dimer is not specific for dvt/pe and elevated levels are also observed in a variety of other conditions where activation of coagulation and fibrinolysis occurs (for example, surgery, trauma, infection, inflammation, pregnancy, cancer).According to the investigation, there is no reconsideration of the performance of vidas d-dimer exclusion ii ref.(b)(4), lot 1008696080.

• 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: sandrine proriol ; 5 rue des aqueducs; craponne, MO 69290 ; FR 69290
• MDR Report Key: 12721176
• MDR Text Key: 281412781
• Report Number: 8020790-2021-00211
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 01/07/2022

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: 04/13/2022
• Device Catalogue Number: 30455-02
• Device Lot Number: 1008696080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/29/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 7 YR