MAUDE Adverse Event Report: BIOMÉRIEUX SA NUCLISENS® LYSIS BUFFER

Catalog Number 280134

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Customer notified biomérieux of discrepant downstream results following testing of the nuclisens® system.Upon using a new lot of lysis buffer, the customer no longer observed colored eluates.Customer stated there was a delay in reporting results up to several days.There were no incorrect results reported to a clinician; therefore, no impact to patient health.Biomérieux investigation will be conducted.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: several tests were performed internally with nuclisens lysis buffer 4x1l ref (b)(4) from several batches, including one concerned by this investigation.In total, twelve (12) lysis buffers ref (b)(4) were tested.Among them, two (2) lysis buffers have been tested on emag (workflow 1a fully automated) and ten (10) on easymag (v1 ) and viral whole blood pre-treatment protocol with specific b protocol).Based on the worst case observed in the field which is easymag, because it includes manual handling steps, only one (1) colored eluate has been obtained with v1 pre-treatment protocol over 80 samples tested and by using several 1l lysis buffers.In conclusion, the tests did not reproduce the issue observed by our customer when the extraction step is performed using the validated pre-treatment protocol.Based on the investigation results, we identified three (3) root causes that lead to colored eluates : poor whole blood sample quality, including hemolyzed, vortexed, not freshly collected samples or samples submitted to freezing/thawing cycles; easymag-related, including tubing clogging or magnets misalignment on easymag; handling practices either during sample pretreatment or automated nucleic acid extraction, especially when a customized protocol is used.In order to optimize next tests, we advise the following recommendations: colored eluates should not be used because they can lead to pcr inhibition; whole blood sample quality : we recommend to homogenize whole blood samples by inverting the tubes up and down 5 times.Vortex should not be used.Please be aware that the samples validated by biomérieux on easymag and emag instruments are whole blood edta.Please note that it is not allowed to centrifuge the tubes in order to remove a part of plasma because it is not anymore a whole blood sample and genomic dna concentration can be too high.The validated pre-treatment protocol for whole blood samples is viral whole blood protocol with 140 l of silica which must be used on easymag and workflow 1a fully automated or workflow 5 must be used on emag.Note : for the easymag pre-treatment protocol or workflow 5 extraction method, the silica premix should be vortexed regularly before addition to the sample into the well.It is also very important to mix the silica premix with the sample into the well with the biohit electronic pipet program 3.If you are working with viscous samples, it is recommended to perform this step twice; easymag and emag regular maintenance should be done in order to clean the tubing system and insure correct alignment of magnets.Please also note that we cannot guarantee the performances of our kits outside of the conditions validated in the ifus or user manual.

• Brand Name: NUCLISENS® LYSIS BUFFER
• Type of Device: NUCLISENS® LYSIS BUFFER
• Manufacturer (Section D): BIOMÉRIEUX SA; 5 rue de berges; grenoble ceddex 01 38024; FR
• Manufacturer (Section G): BIOM[?]RIEUX SA; 5, rue des berges; grenoble cedex 01, 38024 ; FR 38024
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6701914
• MDR Text Key: 79950927
• Report Number: 3002769706-2017-00160
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: CL 1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: 280134
• Device Lot Number: Z018LB1LB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1