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

Catalog Number 30455-02

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

On (b)(6) 2021, a customer from (b)(6) reported to biomérieux that he obtained underestimated results when analyzing patient samples with vidas d-dimer exclusion ii 60t (ref.30455-02, batch number: 1008589420, expiry date: 16/02/2022).The customer analyzed patient sample with vidas d-dimer exclusion ii 60t (ref.30455-02) and obtained a result <45 ng/ml.The same sample was retested on a different section / position of the instrument and the customer obtained the same result.A new patient¿s sample was collected at the laboratory and the test d-dimer was repeated.The value obtained was still <45 ng/ml.The sample was also tested after dilution at 1:5 (dilution made with diluent r1 present in the kit vidas).The result was still negative (no value specified).The patient was (b)(6) with under chemotherapy drug (nilotinib, sold under the brand name tasigna) to treat chronic myeloid leukemia.The customer reported that there was no patient harm or incorrect treatment due to the discrepant result.The customer stated there was no delay in reporting results.To be noted that it was specified that customer does not performed qcv test to verify instrument performance.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A biomerieux internal investigation was performed following notification from a customer from italy reported to biomérieux that he obtained underestimated results when analyzing patient samples with vidas d-dimer exclusion ii 60t (ref.(b)(4), batch number: 1008589420, expiry date: 16/02/2022).Investigation: device history record: the review did not highlight any issue during manufacturing of vidas d-dimer exclusion ii ref (b)(4) ,lot 1008589420.Test/analysis performed.Customer¿s material: 2 frozen samples (citrate plasma) returned by the customer : dates 14-apr and 21-apr.Control charts analysis: the complaint laboratory analyzed the results of 4 internal samples (targets 202 ¿ 397 - 2246 and 6441 ng/ml (feu)) on 7 different batches vidas d-dimer exclusion ii ref (b)(4)including customer¿s lot 1008589420.The analysis of the control charts showed that all results are within specifications.Customer¿s lot is in the trend of the other lots.Tests performed by complaint laboratory: the complaint laboratory tested 4 internal samples (same as control charts analysis above) , on retain kit vidas d-dimer exclusion ii ref (b)(4), lot 1008589420.All samples results are within their expected specifications and similar to those observed before the batch release.There is no evolution over time of the customer¿s lot since its release.The complaints laboratory tested 2 samples returned by the customer on the retain kit vidas d-dimer exclusion ii ref (b)(4) customer¿s lot 1008589420 and on another lot 1008496660 manufactured with other raw material.2 samples results are <45 ng/ml (feu): negative interpretation.Competitor method: the customer¿s sample was sent to an external laboratory to be tested using d-dimer hs 500 (werfen) method.Customer¿s sample gave <215 ng/ml (feu): negative interpretation (reference value < 500 ng/ml (feu)) root cause analysis and conclusion: the negative results observed by the customer was reproduced when testing the samples on vidas d-dimer exclusion ii ref (b)(4), customer¿s lot 1008589420 and another lot 1008496660.Competitor method d-dimer hs 500 (werfen) gave also a negative result.So, the clinical interpretation is identical with both method (clearly under the threshold of 500 ng/ml).The investigation did not identify a root cause of the low results (<45 ng/ml (feu)) obtained for this patient in vidas.According to the investigation, vidas d-dimer exclusion ii ref (b)(4) customer¿s lot 1008589420 is within the expected performance.There is no evolution over time of the batch activity since its release.

• Brand Name: VIDAS D-DIMER EXCLUSION II
• Type of Device: VIDAS® D-DIMER EXCLUSION II
• MDR Report Key: 11816917
• MDR Text Key: 280937547
• Report Number: 8020790-2021-00122
• 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: 07/02/2021

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: 02/16/2022
• Device Catalogue Number: 30455-02
• Device Lot Number: 1008589420
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 06/07/2021
• Supplement Dates FDA Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR