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

Catalog Number 30455

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of discrepant results associated with vidas® d dimer ii (reference 30455).The customer reported a d dimer result of less than 40 ng/ml.The sample was retested three (3) times and tested on a different vidas® system, but the result obtained was less than 40 ng/ml.There was a delay in reporting the results.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) notified biomérieux of discrepant results associated with vidas® d dimer ii (reference 30455).The customer reported a d dimer result of less than 40 ng/ml.The sample was retested three (3) times and tested on a different vidas® system, but the result obtained was less than 40 ng/ml.An internal biomérieux investigation was performed.The analysis of three (3) internal sample charts (two samples with targets at 116 ng/ml and 201 ng/ml and one sample < 45 ng/ml ) on 21 batches vidas ddex ii between lots 171108-0 and 180427-1 showed that all results are within their specifications.Hypothesis: historical experience related to results below 45 ng/ml, there are different elements: an operator error: if the customer forgets to put the spr in the instrument or the sample in the strip.A pre analytic issue: presence of micro clots of fibrin.Improper maintenance of the instrument.As it is mentioned in the package insert in section limitations of the method: "results below the detection limit of 45 ng/ml obtained with the vidas® d-dimer exclusion ii kit are usually linked to poor pre-analytical or incorrect instrument maintenance and therefore, the assay must be repeated." however in this case, as the result below 45 ng/ml was reproduced on several vidas instruments by different operators and using different vidas d-dimer reagents, and because another sample collected later gave also a low concentration of d-dimer, two (2) additional options were considered: a low concentration of d-dimer for this patient due to clinical history or a treatment.A possible interference leading to an underestimation of the d-dimer including a pre-analytic issue it is mentioned in the package insert, section limitations of the method: "interference may be encountered with certain plasmas containing antibodies directed against reagent components.For this reason, assay results should be interpreted taking into consideration the patient's history (clinical probability)".There is no non-conformity linked to the customer's anomaly for vidas d dimer ii.There were no other complaints of this nature.Conclusion: without any sample available, biomérieux cannot explain the low concentration of d-dimer measured for this specific sample.

• Brand Name: VIDAS® D DIMER II
• Type of Device: VIDAS® D DIMER II
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• MDR Report Key: 7014395
• MDR Text Key: 92608614
• Report Number: 3002769706-2017-00355
• 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: 02/01/2018

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 Catalogue Number: 30455
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR