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

A customer in switzerland notified biomérieux of obtaining positive results when testing qc samples using vidas d-dimer exclusion ii 60t (ref.30455-02, batch number 1009034700, expiry date 18-oct-2022) when the expected results were negative on minividas.The issue occurred in the context of an external quality assessment from qualab.Customer result on (b)(6) 2022: in position a1: 548.45 ng/ml.In position a2: 548.45 ng/ml.The returned result was the mean of the two values 548.45 ng/ml ie.0.548 mg/l; expected range 0.44 mg/l [0.34-0.54] mg/l.Calibration of lot 1009034700 was performed on (b)(6) 2022 was conform but rfv s1 value was close to the lower limit of mle range.Qcv results on the mini vidas instrument from (b)(6) 2021, (b)(6) 2022 and (b)(6) 2022 were conform.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 switzerland regarding positive results when testing qc samples using vidas d-dimer exclusion ii 60t (ref.30455-02, batch number 1009034700, expiry date 18-oct-2022) when the expected results were negative on minividas.A biomérieux internal investigation has been completed with the following results: customers results: - with vidas d dimer exclusion ii ref 30455-02 batch 1009034700.Eeq 21-11-he target value = 0.44 mg/l [0.34-0.54] mg/l value obtained : 548.45 ng/ml twice z score = 3.74 **investigation** 1.Device history record.The review did not highlight any issue during manufacturing for vidas d dimer exclusion ii ref 30455-02 batch 1009034700.There is no capa, no non conformity on vidas d dimer exclusion ii ref (b)(4) linked with customer 's complaint.2.Complaint analysis.The analysis of complaints recorded against this lot did not reveal any quality issue for this lot or any systemic quality issue.3.Tests and analysis performed.**product return** the quality controls were not available for investigation.**investigation protocol and obtained results** *** control chart analysis*** the analysis was performed for: four (4) internal samples, close to the cscq quality control targets, at 202, 208, 394 and 585 ng/ml, - seven (7) batches of vidas d dimer exclusion ii ref 30455-02 including the customer¿s lot 1009034700.=> all the samples result complied with the specifications and vidas d dimer exclusion ii ref (b)(4) was in the trend compared to the other lots.**tests performed** all the following tests performed by the complaints laboratory have been performed with the batch 1009034700.** internal samples** - two (2) internal samples targeted at 202 and 585 ng/ml were tested on the retained kit of customer¿s lot vidas d dimer exclusion ii 1009034700.All the results obtained were within specifications.No significant difference of activity was observed for vidas d dimer exclusion ii ref 30455-02 1009034700 compared to those observed before the batch release.**external quality control proficiency probioqual** the complaints laboratory subscribes to probioqual external quality program and test those quality control samples such as an ordinary user.-two (2) probioqual quality controls targeted at 356.5 ng/ml and 358.9 ng/ml were tested with vidas d dimer exclusion ii ref (b)(4).Sample 22hc01 : 359.89 ng/ml.Mean peer group 356.5 ng/ml with cv= 7% range [256.7 ¿ 456.3] ng/ml.Sample 22hc04 : 372.69 ng/ml mean peer group = 358.9 ng/ml ; cv = 5% range [258.4 ¿ 459.4] ng/ml all the results obtained complied to probioqual specifications.The peer group variability complied to the vidas d-dimer exclusion ii between run variability specifications, ie cv< 9%.** external quality control cscq preanalytical** data from cscq package insert: "1.Allow the lyophilisate and dilution fluid, or (bi)distilled water, to return to room temperature (20 - 25 °c).2.Drop the entire lyophilisate to the bottom of the vial, tapping gently if necessary against the vial.3.Carefully open the vial, avoiding any loss of material.Allow air to enter before opening the vial the vial completely.4.Using a certified pipette, add the exact volume of dilution fluid, or (bi)distilled water, as indicated on the label, in one go.(water, as indicated on the label.The diluent should be introduced gently against the wall of the bottle.The use of a syringe to add the diluent is strongly discouraged.5.Close the bottle and let stand, without shaking, for 15 to 30 minutes at room temperature in the dark.6.Homogenize the sample gently: - invert 30 times or - leave for 10 minutes on the roller shaker - without causing foam.7.Check that all the lyophilisate is dissolved and proceed immediately to the analysis.If exceptionally, the analyses cannot be performed immediately, the vial must be kept closed in the refrigerator (except for in the refrigerator (except for the samples for coagulation which cannot be stored).According to the customer feedback, the cscq quality control, after reconstitution, let at room temperature 10 min then put 10 min on a wheel and then vortex before use.French subsidiary has already advised the customer to avoid vortex mixing with the cscq quality control.3.Root cause analysis and conclusion.According to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data for vidas d dimer exclusion ii ref (b)(4) batch and 1009034700.According to the tests performed on vidas d dimer exclusion ii ref (b)(4) no anomaly was highlighted.Without customer's return sample further investigation cannot be pursued.In order to optimize the results obtained on the quality control samples, it is important to remind to the customers.- the importance to respect the instructions for use regarding the homogenization of calibrators and controls vials (using a vortex type mixer) for vidas calibration - to follow the instruction for use mentioned in the package insert of the quality control samples especially regarding the handling of these samples (stability and homogenization).- the importance to perform the required maintenances (user maintenance and preventive maintenance) in order to maintain instrument performances.There is no reconsideration of the performance of vidas d dimer exclusion ii ref (b)(4) batch 1009034700.

• 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: danielle cooper ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 15342532
• MDR Text Key: 302243938
• Report Number: 8020790-2022-00093
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2022
• Device Catalogue Number: 30455-02
• Device Lot Number: 1009034700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1