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

Catalog Number 30455

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

Issue description: on (b)(6), 2023, a customer in serbia notified biomérieux of a potential false negative result with vidas d-dimer exclusion ii 60t (ref.(b)(4), batch 1009826570, expiry date 17-dec-2023) on patient samples.The affected patient had chronic obstructive pulmonary disease and he was on regular prescription of amlodipine and spiriva respimat.He was admitted in hospital on (b)(6), and after two (2) days he tested covid-19 positive.At the hospital admission and during his whole stay, the customer obtained d-dimer results 45 ng/ml for six (6) samples from the same patient with vidas d-dimer exclusion ii 60t (ref.(b)(4), batch 1009826570).During his stay the following therapies were prescribed: alvolamid (levofloxacin), ceftriaxon, captopril (zorkaptil), some probiotic and gastroprotective controloc, azosad.As the results were unusually and unexpectedly low result considering his diagnosis, the customer compared these results to another method (stago); he obtained 530 ng/ml.There is no indication or report from the laboratory that the issue led to any adverse event related to patient's state of health.A biomérieux internal investigation will be initiated.Note: reference (b)(4), is not registered in the united states.The u.S.Similar device is product reference (b)(4).

Manufacturer Narrative

An internal investigation was performed following a notification from a customer from serbia that they obtained false negative results when testing patient samples with vidas®d-dimer exclusion ii¿ - ref (b)(4), lot 1009826570.Device history record the review did not highlight any issue during manufacturing vidas®d-dimer exclusion ii¿ - ref (b)(4), lot 1009826570.Complaint analysis: at the date of investigation, no others complaints were recorded for false negative results on vidas® d-dimer exclusion ii¿ - ref (b)(4), lot 1009826570.Tests/analysis performed, customer¿s material, there was no patient sample return at the time of the complaint.The investigation has been performed with internal samples.Control charts analysis: the complaints laboratory analyzed the results of 4 internal samples targeted at 278 ng/ml ,585 ng/ml 741 ng/ml and 1341 ng/ml on 7 different batches of vidas®d-dimer exclusion ii¿ - ref (b)(4) including customer¿s lot 1009826570.The analysis of the control charts showed that all results were within specifications.Customer¿s lot is in the trend of the other lots.Tests performed by complaint laboratory - test on internal samples: the complaints laboratory tested 4 internal samples with concentrations targeted 278 ng/ml ,585 ng/ml 741 ng/ml and 1341 ng/ml with the retain kit vidas®d-dimer exclusion ii¿ - ref (b)(4), lot 1009826570.All samples results are within their expected specifications.There is no evolution since the batch release.Conclusion: according to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data and the tests performed on retained kits vidas® d-dimer exclusion ii¿ - ref (b)(4), lot 1009826570 using internal samples.Customer¿s issue, were not reproduced by complaints laboratory during the investigation conducted on internal samples materials.Without customer¿s return sample and kit, the investigation cannot be pursued.There is no reconsideration of the performance of vidas® d-dimer exclusion ii¿ - ref (b)(4), lot 1009826570.

• Brand Name: VIDAS® D-DIMER EXCLUSION II ¿
• Type of Device: VIDAS® D-DIMER EXCLUSION II ¿
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'étoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: ines el oueryemmi ; 5 rue des acqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 17325870
• MDR Text Key: 319293419
• Report Number: 8020790-2023-00045
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2023
• Device Catalogue Number: 30455
• Device Lot Number: 1009826570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 08/17/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1