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

Catalog Number 30455-02

Device Problem Low Test Results (2458)

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

Event Date 04/29/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, a customer from (b)(6) notified biomérieux of obtaining underestimated result when testing an external quality control with vidas d dimer exclusion ii 60t (ref.30455-02, lot number1008756000, expiry 17-may-2022) on vidas 3 (ref.412590, serial number: (b)(4) compared to minividas.Indeed, customer reported discrepant result between vidas 3 and minividas when testing a controllab proficiency sample (dd03) of the d-dimer test.According to controllab, the expected range for the external quality control dd03 are from 286 to 477 ng/ml.On the same day ((b)(6) 2022), the customer obtained the following results: (b)(6).As this was an external quality control, it had no impact on the patient.A biomérieux internal investigation will be initiated.Note: reference (b)(4) 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 notification from a customer in brazil that they obtained an underestimated result when testing an external quality control with vidas d dimer exclusion ii 60t (ref.30455-02, lot number1008756000, expiry 17-may-2022) on vidas 3 (ref.412590, serial number: (b)(6) compared to minividas.Investigation device history record this review did not highlight any issues during manufacturing, control or packaging processes for vidas® d-dimer exclusion ii ref 30455-02 lot1008756000.This batch is impacted by the fsca 5333 related to substrate error.The new expiration date was estimated to (b)(6) 2022.Complaint analysis as of the date of this investigation, no other similar complaints have been received on vidas d-dimer exclusion ii ref 30455-02 lot 1008756000.Control chart analysis control chart analysis performed on 4 samples (targets at 202 ng/ml; 208 ng/ml; 767 ng/ml; 585 ng/ml and 2284 ng/ml) using 7 batches of vidas® d-dimer exclusion ii ref 30455-02 including customer's lot 1008756000.Results from the customer's lot were consistent with the other lots.Tests/analysis performed at the date of the investigation, the vidas® d-dimer exclusion ii ref 30455-02 lot 1008756000 was expired, thus no tests could be carried out.However , the complaint laboratory (iu) subscribes to different eqc campaigns, including the one of the french supplier probioqual.An analysis of the results obtained on the 2021 campaign was performed.Indeed, on the reports provided by the supplier, the vidas peer groups are detailed according to the instrument used (mini vidas & vidas pc versus vidas 3).The analysis was performed on the 15 samples of the campaign.Below are the results for the samples with a concentration close to the customer¿s sample **ech 21hc01** mini vidas & vidas pc : target 315.1 range [224.7 - 405.5] vidas 3 : target 331.2 range [238.5 ¿ 423] **ech 21hc07** mini vidas & vidas pc : target 319.2 range [228.1 - 410.3] vidas 3 : target 318.9 range [228.9 - 406.9] **ech 21hc10** mini vidas & vidas pc : target 314.9 range [225.3 ¿ 404.5] vidas 3 : target 321.2 range [231.3 - 411.1 ] **ech 21hc97** mini vidas & vidas pc : target 187.5 range [133.2 - 241.8] vidas 3 : target 190.6 range [137.2 - 244.0] according to probioqual reports, there was no significant difference in the results obtained between the vidas pc/ mini vidas peer group and the vidas 3 peer group.This analysis does not explain the customer's anomaly.Conclusion at the date of the investigation, the vidas® d-dimer exclusion ii ref 30455-02 lot 1008756000 was expired.So no tests could be carried out.According to all information above, no anomaly was highlighted with the analysis of quality data for the kit vidas® d-dimer exclusion ii ref 30455-02 lot 1008756000.Moreover the results obtained with the french supplier, probioqual¿s samples are compliant to the range with the kit vidas® d-dimer exclusion ii ref 30455-02 lot 1008756000, and reports do not show any difference between instruments (mini vidas/ vidas pc and vidas 3).Since there is no similar complaint on this batch, the main hypothesis that could explain the results observed by customer is issue during the pre-analytic step: volume, waiting time, mixing¿ according to the above data, the kit vidas® d-dimer exclusion ii ref 30455-02 lot 1008756000 was within the expected performances.

• 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 ; FR
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 14754183
• MDR Text Key: 300998195
• Report Number: 8020790-2022-00069
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1