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

Catalog Number 30455-02

Device Problem Failure to Calibrate (2440)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of low standard (s1) results leading to invalid calibration in association with the vidas d-dimer exclusion ii assay (ref.30455-02).As no standards results are available, the software cannot calculate the concentration for controls and/or patients.An invalid calibration could lead to a delay in reporting patient results.There is no indication or report from the laboratory that the failed calibrations or subsequent delay led to any adverse event related to any patient's state of health.Product reference 30455-02 is not sold or distributed in the united states; however, a similar product (reference 30455-01) is registered and sold in the united states.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for low standard (s1) results leading to invalid calibration in association with the vidas d-dimer exclusion ii batch 1006739790/190808-1.Customer's material: the customer's kit was not available for evaluation.Complaint trending analysis: no other complaint has been received for the calibration issue on vidas d-dimer exclusion ii batch 1006739790/190808-1.There is neither capa nor non-conformity linked to the customer's issue recorded on vidas d-dimer exclusion ii.Quality control records: the analysis of vidas d-dimer exclusion ii batch 1006739790/190808-1 showed no anomaly during the manufacturing , control and packaging processes.Tests performed: the biomérieux laboratory performed a calibration using the retained kit of vidas d-dimer exclusion ii batch 1006739790/190808-1.The results are within the acceptable ranges and similar to those obtained before the batch release.There was no observation of any evolution over time of calibration results for vidas d-dimer exclusion ii batch 1006739790/190808-1.Testing did not reproduce the customer's issue, namely a calibration failure.It was not possible to obtain the customer's kit and the hypothesis is that the issue can be linked to this specific kit.The vidas d-dimer exclusion ii batch 1006739790/190808-1 performed as expected.

• Brand Name: VIDAS® D-DIMER EXCLUSION II
• Type of Device: VIDAS® D-DIMER EXCLUSION II
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• MDR Report Key: 8543815
• MDR Text Key: 160779495
• Report Number: 8020790-2019-00026
• 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: 06/08/2019

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: 08/08/2019
• Device Catalogue Number: 30455-02
• Device Lot Number: 1006739790
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 05/17/2019
• Supplement Dates FDA Received: 06/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1