MAUDE Adverse Event Report: BIOMERIEUX SA NUCLISENS® LYSIS BUFFER

Model Number 280134

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) reported to biomérieux that they observed yellow colored eluates and inhibition on downstream applications while using nuclisens lysis buffer to extract the nucleic acids.The issue occurred intermittently and the other results for non-colored eluates are under the expected values.The customer spiked the colored eluates with a positive control and the result was inhibited.After re-extraction, a good result was obtained.On the seven (7) blood samples tested, the b globin was only detected on three (3).The customer uses a generic protocol which they have obtained successful results in the past.Since a positive control was used, an incorrect result was not communicated to the physician and no patient was incorrectly treated.However, the customer did report there was a delay greater than a day due to the re-extraction and retest of the impacted samples.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

A customer in (b)(6) reported to biomérieux that they observed yellow colored eluates and inhibition on downstream applications while extracting nucleic acids with easymag® lysis buffer (lot z018na1lb).An investigation was performed.An investigation was conducted for nuclisens® lysis buffer 4x1l, reference 280134, lots z018la1lb, z018lb1lb, z018kb1lb, z018na1lb and z019ea1lb.Customers observed an increase of colored eluates obtained after whole blood samples extractions with easymag® and emag® instruments.Several tests were conducted with nuclisens® lysis buffer 4x1l (ref 280134) from several batches, including lot z018na1lb.In total, twelve lysis buffers were tested.Among them, two lysis buffers were tested on emag® (workflow 1a fully automated) and ten 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®, as it includes manual handling steps, only one colored eluate was obtained with v1 pre-treatment protocol from 80 samples tested by using several 1l lysis buffers.In conclusion, tests did not reproduce the issue observed by customers when the extraction step is performed using the validated pre-treatment protocol.Based on the investigation results, we identified three 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.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®.

• Brand Name: NUCLISENS® LYSIS BUFFER
• Type of Device: NUCLISENS® LYSIS BUFFER
• Manufacturer (Section D): BIOMERIEUX SA; 5, rue des berges; cedex 01; grenoble, 38024 ; FR 38024
• Manufacturer (Section G): BIOMERIEUX SA; 5, rue des berges; cedex 01; 38024 ; FR 38024
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6735453
• MDR Text Key: 80791208
• Report Number: 3002769706-2017-00203
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: C1 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Model Number: 280134
• Device Lot Number: Z018NA1LB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/24/2017
• Supplement Dates Manufacturer Received: 08/25/2017
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2017
• 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