MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS D-DIMER EXCLUSION II 60T; VIDAS D-DIMER EXCLUSION II 60T - 30455-02

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 discrepant results when testing a patient¿s samples with vidas® d-dimer exclusion ii 60t ref.30455-02 lot 1007944750 on mini-vidas® instrument and with another unspecified method.It was reported that covid was suspected for this patient.The patient was being treated with: tramal and sorrisal.The customer performed a d-dimer test on a patient¿s sample with an unspecified method and the result was reported to be ¿very high positive¿: sample pure = 13546 ng/ml , diluted 1/2 = 11283 ng/ml and 1/8 = 5449 ng/ml, retest same sample pure = 16154 ng/ml and diluted 1/8 = 4682 ng/ml.Then a sample from this patient was tested with vidas® d-dimer exclusion ii 60t ref.30455-02 lot 1007944750 and the result was low : result obtained pure = 134,36 ng/ml (fibrinogen equivalent unit - feu) and diluted 1/2 = 194,04 ng/ml (feu).It was not indicated if the tests with vidas® and with the other method were performed on the same sample.The customer indicated that the results were not sent to the doctor or patient.There is no indication or report from the customer that the discrepant results led to any adverse event related to the patient's state of health.Ref (b)(4) is not registered with the fda for use in the united states.According to trackit, the registration status for ref 30455-02 is "on hold." however, a similar product, ref30455-02, is registered with the fda for use in the united states (k141133).A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of discrepant results when testing a patient¿s samples with vidas® d-dimer exclusion ii 60t ref.(b)(4); lot 1007944750 on mini-vidas® instrument and with another method.The customer was unable to provide samples for investigational testing.Historical review- a review of capas, non-conformities, and complaints related to vidas dex ii (ref (b)(4), lot 1007944750/ 210217-1) was performed and did not identify any capas, non-conformities, or other complaints for the same issue.Batch history records- there were no anomalies during the manufacturing, control and packaging processes for vidas dex ii ref (b)(4); lot 1007944750/ 210217-1.Control charts analysis- the complaint laboratory observed 5 internal samples on 10 different batches of vidas dex ii ref (b)(4) including customer¿s lot (1007944750/ 210217-1).The analysis of the control charts showed that all results are within specifications and the customer¿s lot is in the trend with the other lots.Tests performed by complaint laboratory: the complaint laboratory analyzed three (3) internal samples on retain kits of vidas dex ii (ref (b)(4), lot 1007944750/ 210217-1).All internal sample results are within their expected ranges.There has been no drift of the customer¿s lot since its release.Conclusion: since the customer was unable to submit samples for investigational testing, additional investigation cannot be performed and the root cause for the customer's issue remains undetermined.The investigation has concluded that the vidas dex ii (ref (b)(4), lot 1007944750/ 210217-1) is performing as intended.See h10.

• Brand Name: VIDAS D-DIMER EXCLUSION II 60T
• Type of Device: VIDAS D-DIMER EXCLUSION II 60T - 30455-02
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• MDR Report Key: 10173932
• MDR Text Key: 205551095
• Report Number: 8020790-2020-00046
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/17/2021
• Device Catalogue Number: 30455-02
• Device Lot Number: 1007944750
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1