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

Catalog Number 30455-02

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of obtaining false negative d-dimer results for two samples collected from the same patient in association with the vidas® d-dimer exclusion ii 60t tests (ref (b)(4), batch 1007857140).Note: product reference (b)(4) is not sold or distributed in the united states; however, a similar product (reference (b)(4) is registered and sold in the united states.The vidas® d-dimer exclusion ii 60t tests batch 1007857140 obtained results of < 45 ng/ml for both samples.Biomérieux customer service requested the results from the most recent qcv test; the customer stated they do not perform qcv on their vidas® instrument.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to the patient's state of health.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in italy regarding false negative d-dimer results for two samples collected form the same patient in association with the vidas® d-dimer exclusion ii 60t tests (ref 30455-02, batch 1007857140).A biomérieux internal investigation has been completed with the following results: analysis of the quality data of the batch (1007857140 / 210115-0) showed that all plasmas tested during the activity control were within expected standards.In addition, no anomaly during the manufacturing, control and packaging stages were identified.Several internal plasmas were tested on eight (8) batches of vidas d-dimer exclusion ii ref.30455 including the batch cited by the customer (210115-0).The batch of vidas d-dimer exclusion ii (210115-0) was in the trend of the other batches.The customer's samples were tested on the customer's lot of vidas d-dimer exclusion ii (lot 1007857140 / 210115-0) with the following results: the results obtained for the calibration and the controls comply with the mle data.Sample 1: 30 rfv and <45 ng / ml.Sample 2: 24 rfv and <45 ng / ml.Due to lack of volume only the second sample was tested on another lot vidas d-dimer exclusion ii (lot 210307-0) at the investigation unit laboratory with the following results: the results obtained for the calibration and the controls comply with the mle.Sample 2: 18 rfv and <45 ng / ml.The customer's results were confirmed on the batch cited by the customer vidas d-dimer exclusion ii (batch 1007857140 / 210115-0) and a second lot (lot 210307-0).The sample was sent to bcl laboratory for concurrent testing using biominis: d - dimer hs 500, acl top, il.The results obtained were <215 ng / ml.There was no interpretation discrepancy between the two techniques, confirming the customer obtained accurate results.The vidas d-dimer exclusion ii (lot 1007857140 / 210115-0) is performing as intended within its performance specifications.

• 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, rhone; 69280 ; FR 69280
• MDR Report Key: 10217275
• MDR Text Key: 200668820
• Report Number: 8020790-2020-00054
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• PMA/PMN Number: K112818
• 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: 10/08/2020

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: 01/15/2021
• Device Catalogue Number: 30455-02
• Device Lot Number: 1007857140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1