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

Catalog Number 30455-02

Device Problem False Negative Result (1225)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer from (b)(6) notified biomérieux of obtaining false negative results when performing reproducibility testing with an internal quality control, in association with vidas® d-dimer exclusion ii (ref.30455-02, lot 1007479470).Product reference 30455-02 is not sold or distributed in the united states; however, a similar product (reference 30455-01) is registered and sold in the united states.The results were as follows: cqi level 1: a total of 22 values with an average of 512.36ng /ml, specification cv = 9%, cv obtained = 6.78% compliant.However, there were cqi values that were below the test decision threshold.Six values were below 500ng /ml which would result in an interpretation change (false negative).As there is no patient associated with this internal quality control testing, there was no adverse impact to any patient's state of health as a result of the testing.The customer stated that no patient samples were retested.The customer reported that results observed for patient samples tested with vidas d-dimer exclusion ii 60t, lot 1007479470, were in line with the final diagnosis (no inconsistency with clinic / symptoms and no return from physicians for misdiagnosis).A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from france notified biomérieux of obtaining false negative results when performing reproducibility testing with an internal quality control with the vidas® d-dimer exclusion ii (dexii) assay (ref.30455-02, lot 1007479470).(us similar product is reference 30455-01).An internal biomérieux investigation was performed.The customer was unable to submit the sample for the investigation.A complaint trend analysis found no recurrence of the customer¿s complaint on vidas dexii, lot 1007479470/200706-0.Batch history records were reviewed, and there was no anomaly during the manufacturing , control and packaging processes for the impacted lot.A control charts analysis was done observing four internal samples on 10 different batches of vidas dexii, including customer¿s impacted lot 1007479470/200706-0, showing all results are within specifications; customer¿s lot is in the trend of the other lots.Results from internal testing on four internal samples on retained kit of vidas dexii, lot 1007479470/200706-0 were within their expected specifications.There was no drift of the customer¿s batch since the batch release.Conclusion: according to the above data , vidas dexii reference 30455-02 lot 1007479470/200706-0 is within the expected performance.Without the customer¿s sample, further investigation could not be pursued nor a root cause proposed.Quality controls are not identical to patient samples; qc manufacturing process can affect sample matrix and control results.Moreover, it is mentioned in the clsi guideline ep14-a3 that processed samples used as qc material (e.G eqa) can have matrix effect.

• Brand Name: VIDAS D-DIMER EXCLUSION II 60T
• Type of Device: VIDAS D-DIMER EXCLUSION II 60T
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 9678425
• MDR Text Key: 207752256
• Report Number: 8020790-2020-00014
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

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: 07/06/2020
• Device Catalogue Number: 30455-02
• Device Lot Number: 1007479470
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1